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• W2093770110 abstract "In women with polycystic ovary syndrome, chromium picolinate (200 μg/d) improves glucose tolerance compared with placebo but does not improve ovulatory frequency or hormonal parameters. This pilot study indicates that future studies in the polycystic ovary syndrome population should examine higher dosages or longer durations of treatment. In women with polycystic ovary syndrome, chromium picolinate (200 μg/d) improves glucose tolerance compared with placebo but does not improve ovulatory frequency or hormonal parameters. This pilot study indicates that future studies in the polycystic ovary syndrome population should examine higher dosages or longer durations of treatment. Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive-age women, affecting 5%–10% of this population (1Knochenhauer E.S. Key T.J. Kahsar-Miller M. Waggoner W. Boots L.R. Azziz R. Prevalence of the polycystic ovary syndrome in unselected black and white women of the southeastern United States a prospective study.J Clin Endocrinol Metab. 1998; 83: 3078-3082Crossref PubMed Scopus (1496) Google Scholar). Women with PCOS face varying degrees of hirsuitism, obesity, irregular menses, and infertility. Over the long term, women with PCOS face increased risks for developing type 2 diabetes and dyslipidemia (2Solomon C.G. The epidemiology of polycystic ovary syndrome. Prevalence and associated disease risks.Endocrinol Metab Clin North Am. 1999; 28: 247-263Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar).Insulin resistance and the resultant hyperinsulinemia are key metabolic features in the pathogenesis of PCOS (3Conway G.S. Honour J.W. Jacobs H.S. Heterogeneity of the polycystic ovary syndrome clinical, endocrine and ultrasound features in 556 patients.Clin Endocrinol. 1989; 30: 459-470Crossref PubMed Scopus (420) Google Scholar, 4Nestler J.E. Jakubowicz D.J. Lean women with polycystic ovary syndrome respond to insulin reduction with decreases in ovarian P450c17 alpha activity and serum androgens.J Clin Endocrinol Metab. 1997; 82: 4075-4079Crossref PubMed Google Scholar). Both lean and obese women with PCOS have insulin resistance, although it is more pronounced in obese women (5Grulet H. Hecart A.C. Delemer B. Gross A. Sulmont V. Leutenegger M. et al.Roles of LH and insulin resistance in lean and obese polycystic ovary syndrome.Clin Endocrinol. 1993; 38: 621-626Crossref PubMed Scopus (63) Google Scholar, 6Dunaif A. Segal K.R. Futterweit W. Dobrjansky A. Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome.Diabetes. 1989; 38: 1165-1174Crossref PubMed Google Scholar). Insulin sensitizers have been shown to regulate menstrual cycles and improve rates of spontaneous ovulation (7Sepilian V. Nagamani M. Effects of rosiglitazone in obese women with polycystic ovary syndrome and severe insulin resistance.J Clin Endocrinol Metab. 2005; 90: 60-65Crossref PubMed Scopus (109) Google Scholar, 8Morin-Papunen L.C. Koivunen R.M. Ruokonen A. Martikainen H.K. Metformin therapy improves the menstrual pattern with minimal endocrine and metabolic effects in women with polycystic ovary syndrome.Fertil Steril. 1998; 69: 691-696Abstract Full Text Full Text PDF PubMed Scopus (262) Google Scholar, 9Nestler J.E. Jakubowicz D.J. Evans W.S. Pasquali R. Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome.N Engl J Med. 1998; 338: 1876-1880Crossref PubMed Scopus (717) Google Scholar, 10Brettenthaler N. De Geyter C. Huber P.R. Keller U. Effect of the insulin sensitizer pioglitazone on insulin resistance, hyperandrogenism, and ovulatory dysfunction in women with polycystic ovary syndrome.J Clin Endocrinol Metab. 2004; 89: 3835-3840Crossref PubMed Scopus (203) Google Scholar, 11Cataldo N.A. Abbasi F. McLaughlin T.L. Lamendola C. Reaven G.M. Improvement in insulin sensitivity followed by ovulation and pregnancy in a woman with polycystic ovary syndrome who was treated with rosiglitazone.Fertil Steril. 2001; 76: 1057-1059Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 12Baillargeon J.P. Jakubowicz D.J. Iuorno M.J. Jakubowicz S. Nestler J.E. Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity.Fertil Steril. 2004; 82: 893-902Abstract Full Text Full Text PDF PubMed Scopus (242) Google Scholar, 13Glueck C.J. Moreira A. Goldenberg N. Sieve L. Wang P. Pioglitazone and metformin in obese women with polycystic ovary syndrome not optimally responsive to metformin.Hum Reprod. 2003; 18: 1618-1625Crossref PubMed Scopus (98) Google Scholar).Trivalent chromium is an essential element that plays a role in glucose and insulin homeostasis. Chromium deficiency as a cause of glucose intolerance was recognized first in 1977, when a trauma patient receiving total parenteral nutrition developed severe diabetes refractory to insulin. Symptoms completely resolved when chromium chloride was added to the total parenteral nutrition (14Jeejeebhoy K.N. Chu R.C. Marliss E.B. Greenberg G.R. Bruce-Robertson A. Chromium deficiency, glucose intolerance, and neuropathy reversed by chromium supplementation, in a patient receiving long-term total parenteral nutrition.Am J Clin Nutr. 1977; 30: 531-538PubMed Google Scholar). Until recently, not much was known about the mechanism of chromium action other than that it appeared to improve the effects of insulin and worked at the level of the cell membrane (15Mertz W. Chromium research from a distance from 1959 to 1980.J Am Coll Nutr. 1998; 17: 544-547Crossref PubMed Scopus (67) Google Scholar). The interaction between chromium and insulin has been elucidated by the discovery of low–molecular weight chromium-binding substance, which binds chromium and the insulin receptor, activating the insulin receptor’s kinase activity (16Davis C.M. Vincent J.B. Chromium oligopeptide activates insulin receptor tyrosine kinase activity.Biochemistry. 1997; 36: 4382-4385Crossref PubMed Scopus (253) Google Scholar, 17Vincent J.B. Mechanisms of chromium action low-molecular-weight chromium-binding substance.J Am Coll Nutr. 1999; 18: 6-12Crossref PubMed Scopus (137) Google Scholar).In patients with impaired glucose tolerance on a low-chromium diet, chromium supplementation significantly improved glucose and insulin values after an oral glucose challenge (18Anderson R.A. Polansky M.M. Bryden N.A. Canary J.J. Supplemental-chromium effects on glucose, insulin, glucagon, and urinary chromium losses in subjects consuming controlled low-chromium diets.Am J Clin Nutr. 1991; 54: 909-916PubMed Google Scholar). In a randomized, double-blind, placebo-controlled study in type 2 diabetics, fasting and 2-hour insulin levels were improved after 2 and 4 months’ treatment with both the 200-μg/d and the 1,000-μg/d dose of chromium picolinate compared with placebo (19Anderson R.A. Cheng N. Bryden N.A. Polansky M.M. Chi J. Feng J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes.Diabetes. 1997; 46: 1786-1791Crossref PubMed Google Scholar).Because other insulin sensitizers have been shown to improve rates of spontaneous ovulation, we sought to determine whether chromium supplementation would change insulin sensitivity in women with PCOS and restore normal ovulation. Approval for this study was obtained from the institutional review board of the University of Texas Health Science Center at San Antonio.Ten nonpregnant women, aged 18 to 39 years and who had established PCOS according to the 1990 National Institutes of Health criteria, were allocated via random number table to treatment with oral chromium picolinate (200 μg/d) or to placebo for 4 months. Both subjects and physicians were blinded to treatment.Measurement of serum hormonal and metabolic parameters and a 2-hour oral glucose tolerance test after a 75-g glucose load were obtained before and after treatment. Subjects also underwent a frequently sampled IV glucose tolerance test before and after treatment, and insulin sensitivity was assessed by the minimal model approach (20Bergman R.N. Ider Y.Z. Bowden C.R. Cobelli C. Quantitative estimation of insulin sensitivity.Am J Physiol. 1979; 236: E667-E677PubMed Google Scholar).Subjects were asked to keep a menstrual calendar and basal body temperature chart to document ovulation. On cycle day 26 of each cycle, a serum P level was drawn to confirm evidence of ovulation by basal body temperature.Subjects were instructed not to use hormonal methods of contraception or intrauterine devices during the study. Women attempting pregnancy were advised to take a folate supplement during the study. Subjects were encouraged to not change their diet or exercise plan from their established routines for the duration of the study.Changes in insulin sensitivity and ovulation rates were the main outcome measures. Glucose tolerance and metabolic and hormonal parameters were secondary outcomes. For parametric outcomes, the efficacy of treatment (chromium vs. placebo; within-subject effects before vs. after treatment) was compared by repeated measures analysis of variance. Ovulation rates were compared by Fisher’s exact test.Six patients were randomized to treatment with chromium, and four patients, to treatment with placebo. There were no significant differences in baseline characteristics between the treatment groups, including age, body mass index, and number of menses per year. The ethnic background of the patients (50% Caucasian, 50% Mexican American) was similar to that seen in our practice, and the distribution was similar for treatment groups. No clinical adverse events occurred during this study.Treatment with chromium was not associated with any significant differences in serum hormone levels, insulin sensitivity, fasting glucose, fasting insulin, triglycerides, or cholesterol (Table 1).TABLE 1Hormonal and metabolic parameters at baseline and after 4 months’ treatment.ChromiumPlaceboParameterBaselineAfter treatmentBaselineAfter treatmentTotal testosterone (ng/dL)aNo comparison is statistically significant.55.3 ± 5.260.5 ± 8.458.3 ± 7.054.0 ± 5.5Free testosterone (pg/mL)aNo comparison is statistically significant.3.2 ± 0.53.2 ± 0.32.9 ± 0.42.9 ± 0.6DHEAS (μg/dL)aNo comparison is statistically significant.211.2 ± 28.5214.5 ± 46.8220.3 ± 53.1254.3 ± 52.8FSH (mIU/mL)aNo comparison is statistically significant.4.1 ± 0.33.6 ± 0.34.9 ± 0.95.7 ± 1.5LH (mIU/mL)aNo comparison is statistically significant.6.4 ± 1.85.8 ± 1.19.8 ± 4.08.4 ± 3.8Insulin sensitivity (mU/L−1 · min−1)aNo comparison is statistically significant.0.68 ± 0.140.81 ± 0.221.12 ± 0.201.02 ± 0.31Fasting glucose (mg/dL)aNo comparison is statistically significant.96.2 ± 3.598.0 ± 5.588.5 ± 3.291.5 ± 3.2Fasting insulin (mU/L)aNo comparison is statistically significant.54.5 ± 18.553.9 ± 16.437.7 ± 12.728.1 ± 1.8OGTT 1 h glucose (mg/dL)bNo significant difference, baseline vs. after treatment.cP<.05, chromium vs. placebo (by repeated-measures analysis of variance).177.0 ± 16.3158.2 ± 16.1132.8 ± 9.2172.0 ± 22.1OGTT 2 h glucose (mg/dL)bNo significant difference, baseline vs. after treatment.cP<.05, chromium vs. placebo (by repeated-measures analysis of variance).134.8 ± 13.6116.3 ± 14.2112.5 ± 9.3136.3 ± 10.0Triglycerides (mg/dL)aNo comparison is statistically significant.145.8 ± 20.3121.6 ± 14.986.8 ± 24.675.8 ± 19.5Cholesterol (mg/dL)aNo comparison is statistically significant.186.2 ± 17.1173.8 ± 12.9154.5 ± 14.9150.5 ± 20.2Note: Values are mean ± SEM.Lucidi. Chromium supplementation in polycystic ovary syndrome. Fertil Steril 2005.a No comparison is statistically significant.b No significant difference, baseline vs. after treatment.c P<.05, chromium vs. placebo (by repeated-measures analysis of variance). Open table in a new tab Plasma glucose levels at 1 and 2 hours during the oral glucose tolerance test were not significantly different when comparing baseline with the case after treatment. However, because at both 1 and 2 hours the plasma glucose decreased with chromium but increased with placebo (i.e., the effect was in opposite directions), there was a significant difference for these parameters when comparing treatment effect (chromium vs. placebo; within-subject effects before vs. after treatment).Two patients (one in each treatment group) ovulated twice, and one patient from the placebo group ovulated once during the 4 months of the study. The remaining patients had no evidence of ovulation by basal body temperature chart or serum P. Therefore, of 24 possible ovulatory cycles in the chromium group (four cycles for six patients), 8% (2/24) were ovulatory; and of 16 possible ovulatory cycles in the placebo group (four cycles for four patients), 19% (3 of 16) were ovulatory. This difference was not statistically significant (P=.63).After 4 months’ treatment with chromium picolinate (200 μg/d orally), there were no significant differences in the primary outcome measures, namely ovulation rates and insulin sensitivity, in the PCOS patients studied. There was, however, a significant improvement in glucose tolerance at 1 and 2 hours. This improvement in plasma glucose is consistent with prior studies (18Anderson R.A. Polansky M.M. Bryden N.A. Canary J.J. Supplemental-chromium effects on glucose, insulin, glucagon, and urinary chromium losses in subjects consuming controlled low-chromium diets.Am J Clin Nutr. 1991; 54: 909-916PubMed Google Scholar, 19Anderson R.A. Cheng N. Bryden N.A. Polansky M.M. Chi J. Feng J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes.Diabetes. 1997; 46: 1786-1791Crossref PubMed Google Scholar, 21Anderson R.A. Chromium, glucose intolerance and diabetes.J Am Coll Nutr. 1998; 17: 548-555Crossref PubMed Scopus (372) Google Scholar). Although the plasma glucose after treatment did not change significantly from baseline, there were significant differences when comparing chromium with placebo. We believe that these differences in plasma glucose are caused by worsening of insulin resistance in the placebo group.Failure to show a significant effect of chromium picolinate on ovulation rate or insulin sensitivity in PCOS patients may be because of the short duration of the study (4 months), small treatment dose (200 μg/d), or small sample size. Prior studies have shown an effect after ≤4 months (18Anderson R.A. Polansky M.M. Bryden N.A. Canary J.J. Supplemental-chromium effects on glucose, insulin, glucagon, and urinary chromium losses in subjects consuming controlled low-chromium diets.Am J Clin Nutr. 1991; 54: 909-916PubMed Google Scholar, 19Anderson R.A. Cheng N. Bryden N.A. Polansky M.M. Chi J. Feng J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes.Diabetes. 1997; 46: 1786-1791Crossref PubMed Google Scholar); however, the effect was greatest with 1,000 μg/d dosing. Assuming a 16% ovulation rate in the placebo group (22Goldzieher J. Green J. The polycystic ovary. I. Clinical and histologic features.J Clin Endocrinol Metab. 1962; 22: 325-338Crossref PubMed Scopus (272) Google Scholar) and an 80% ovulation rate in the chromium group, on the basis of studies with metformin (8Morin-Papunen L.C. Koivunen R.M. Ruokonen A. Martikainen H.K. Metformin therapy improves the menstrual pattern with minimal endocrine and metabolic effects in women with polycystic ovary syndrome.Fertil Steril. 1998; 69: 691-696Abstract Full Text Full Text PDF PubMed Scopus (262) Google Scholar, 9Nestler J.E. Jakubowicz D.J. Evans W.S. Pasquali R. Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome.N Engl J Med. 1998; 338: 1876-1880Crossref PubMed Scopus (717) Google Scholar) and with α = 0.05, we would need 10 patients in each group to achieve a power of 0.80. Smaller differences, as implied by this pilot study, would require larger sample sizes. This pilot study indicates that future studies in the PCOS population should examine higher dosages or longer durations of treatment. Future studies in the PCOS population may corroborate the positive effect that we saw on improved glucose tolerance. Additional findings may be discovered with a larger sample size, longer duration of treatment, or higher doses. Also, chromium picolinate may play a role as a supplement to treatment with other insulin sensitizers, which was not examined in the current study. Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive-age women, affecting 5%–10% of this population (1Knochenhauer E.S. Key T.J. Kahsar-Miller M. Waggoner W. Boots L.R. Azziz R. Prevalence of the polycystic ovary syndrome in unselected black and white women of the southeastern United States a prospective study.J Clin Endocrinol Metab. 1998; 83: 3078-3082Crossref PubMed Scopus (1496) Google Scholar). Women with PCOS face varying degrees of hirsuitism, obesity, irregular menses, and infertility. Over the long term, women with PCOS face increased risks for developing type 2 diabetes and dyslipidemia (2Solomon C.G. The epidemiology of polycystic ovary syndrome. Prevalence and associated disease risks.Endocrinol Metab Clin North Am. 1999; 28: 247-263Abstract Full Text Full Text PDF PubMed Scopus (208) Google Scholar). Insulin resistance and the resultant hyperinsulinemia are key metabolic features in the pathogenesis of PCOS (3Conway G.S. Honour J.W. Jacobs H.S. Heterogeneity of the polycystic ovary syndrome clinical, endocrine and ultrasound features in 556 patients.Clin Endocrinol. 1989; 30: 459-470Crossref PubMed Scopus (420) Google Scholar, 4Nestler J.E. Jakubowicz D.J. Lean women with polycystic ovary syndrome respond to insulin reduction with decreases in ovarian P450c17 alpha activity and serum androgens.J Clin Endocrinol Metab. 1997; 82: 4075-4079Crossref PubMed Google Scholar). Both lean and obese women with PCOS have insulin resistance, although it is more pronounced in obese women (5Grulet H. Hecart A.C. Delemer B. Gross A. Sulmont V. Leutenegger M. et al.Roles of LH and insulin resistance in lean and obese polycystic ovary syndrome.Clin Endocrinol. 1993; 38: 621-626Crossref PubMed Scopus (63) Google Scholar, 6Dunaif A. Segal K.R. Futterweit W. Dobrjansky A. Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome.Diabetes. 1989; 38: 1165-1174Crossref PubMed Google Scholar). Insulin sensitizers have been shown to regulate menstrual cycles and improve rates of spontaneous ovulation (7Sepilian V. Nagamani M. Effects of rosiglitazone in obese women with polycystic ovary syndrome and severe insulin resistance.J Clin Endocrinol Metab. 2005; 90: 60-65Crossref PubMed Scopus (109) Google Scholar, 8Morin-Papunen L.C. Koivunen R.M. Ruokonen A. Martikainen H.K. Metformin therapy improves the menstrual pattern with minimal endocrine and metabolic effects in women with polycystic ovary syndrome.Fertil Steril. 1998; 69: 691-696Abstract Full Text Full Text PDF PubMed Scopus (262) Google Scholar, 9Nestler J.E. Jakubowicz D.J. Evans W.S. Pasquali R. Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome.N Engl J Med. 1998; 338: 1876-1880Crossref PubMed Scopus (717) Google Scholar, 10Brettenthaler N. De Geyter C. Huber P.R. Keller U. Effect of the insulin sensitizer pioglitazone on insulin resistance, hyperandrogenism, and ovulatory dysfunction in women with polycystic ovary syndrome.J Clin Endocrinol Metab. 2004; 89: 3835-3840Crossref PubMed Scopus (203) Google Scholar, 11Cataldo N.A. Abbasi F. McLaughlin T.L. Lamendola C. Reaven G.M. Improvement in insulin sensitivity followed by ovulation and pregnancy in a woman with polycystic ovary syndrome who was treated with rosiglitazone.Fertil Steril. 2001; 76: 1057-1059Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 12Baillargeon J.P. Jakubowicz D.J. Iuorno M.J. Jakubowicz S. Nestler J.E. Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity.Fertil Steril. 2004; 82: 893-902Abstract Full Text Full Text PDF PubMed Scopus (242) Google Scholar, 13Glueck C.J. Moreira A. Goldenberg N. Sieve L. Wang P. Pioglitazone and metformin in obese women with polycystic ovary syndrome not optimally responsive to metformin.Hum Reprod. 2003; 18: 1618-1625Crossref PubMed Scopus (98) Google Scholar). Trivalent chromium is an essential element that plays a role in glucose and insulin homeostasis. Chromium deficiency as a cause of glucose intolerance was recognized first in 1977, when a trauma patient receiving total parenteral nutrition developed severe diabetes refractory to insulin. Symptoms completely resolved when chromium chloride was added to the total parenteral nutrition (14Jeejeebhoy K.N. Chu R.C. Marliss E.B. Greenberg G.R. Bruce-Robertson A. Chromium deficiency, glucose intolerance, and neuropathy reversed by chromium supplementation, in a patient receiving long-term total parenteral nutrition.Am J Clin Nutr. 1977; 30: 531-538PubMed Google Scholar). Until recently, not much was known about the mechanism of chromium action other than that it appeared to improve the effects of insulin and worked at the level of the cell membrane (15Mertz W. Chromium research from a distance from 1959 to 1980.J Am Coll Nutr. 1998; 17: 544-547Crossref PubMed Scopus (67) Google Scholar). The interaction between chromium and insulin has been elucidated by the discovery of low–molecular weight chromium-binding substance, which binds chromium and the insulin receptor, activating the insulin receptor’s kinase activity (16Davis C.M. Vincent J.B. Chromium oligopeptide activates insulin receptor tyrosine kinase activity.Biochemistry. 1997; 36: 4382-4385Crossref PubMed Scopus (253) Google Scholar, 17Vincent J.B. Mechanisms of chromium action low-molecular-weight chromium-binding substance.J Am Coll Nutr. 1999; 18: 6-12Crossref PubMed Scopus (137) Google Scholar). In patients with impaired glucose tolerance on a low-chromium diet, chromium supplementation significantly improved glucose and insulin values after an oral glucose challenge (18Anderson R.A. Polansky M.M. Bryden N.A. Canary J.J. Supplemental-chromium effects on glucose, insulin, glucagon, and urinary chromium losses in subjects consuming controlled low-chromium diets.Am J Clin Nutr. 1991; 54: 909-916PubMed Google Scholar). In a randomized, double-blind, placebo-controlled study in type 2 diabetics, fasting and 2-hour insulin levels were improved after 2 and 4 months’ treatment with both the 200-μg/d and the 1,000-μg/d dose of chromium picolinate compared with placebo (19Anderson R.A. Cheng N. Bryden N.A. Polansky M.M. Chi J. Feng J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes.Diabetes. 1997; 46: 1786-1791Crossref PubMed Google Scholar). Because other insulin sensitizers have been shown to improve rates of spontaneous ovulation, we sought to determine whether chromium supplementation would change insulin sensitivity in women with PCOS and restore normal ovulation. Approval for this study was obtained from the institutional review board of the University of Texas Health Science Center at San Antonio. Ten nonpregnant women, aged 18 to 39 years and who had established PCOS according to the 1990 National Institutes of Health criteria, were allocated via random number table to treatment with oral chromium picolinate (200 μg/d) or to placebo for 4 months. Both subjects and physicians were blinded to treatment. Measurement of serum hormonal and metabolic parameters and a 2-hour oral glucose tolerance test after a 75-g glucose load were obtained before and after treatment. Subjects also underwent a frequently sampled IV glucose tolerance test before and after treatment, and insulin sensitivity was assessed by the minimal model approach (20Bergman R.N. Ider Y.Z. Bowden C.R. Cobelli C. Quantitative estimation of insulin sensitivity.Am J Physiol. 1979; 236: E667-E677PubMed Google Scholar). Subjects were asked to keep a menstrual calendar and basal body temperature chart to document ovulation. On cycle day 26 of each cycle, a serum P level was drawn to confirm evidence of ovulation by basal body temperature. Subjects were instructed not to use hormonal methods of contraception or intrauterine devices during the study. Women attempting pregnancy were advised to take a folate supplement during the study. Subjects were encouraged to not change their diet or exercise plan from their established routines for the duration of the study. Changes in insulin sensitivity and ovulation rates were the main outcome measures. Glucose tolerance and metabolic and hormonal parameters were secondary outcomes. For parametric outcomes, the efficacy of treatment (chromium vs. placebo; within-subject effects before vs. after treatment) was compared by repeated measures analysis of variance. Ovulation rates were compared by Fisher’s exact test. Six patients were randomized to treatment with chromium, and four patients, to treatment with placebo. There were no significant differences in baseline characteristics between the treatment groups, including age, body mass index, and number of menses per year. The ethnic background of the patients (50% Caucasian, 50% Mexican American) was similar to that seen in our practice, and the distribution was similar for treatment groups. No clinical adverse events occurred during this study. Treatment with chromium was not associated with any significant differences in serum hormone levels, insulin sensitivity, fasting glucose, fasting insulin, triglycerides, or cholesterol (Table 1). Note: Values are mean ± SEM. Lucidi. Chromium supplementation in polycystic ovary syndrome. Fertil Steril 2005. Plasma glucose levels at 1 and 2 hours during the oral glucose tolerance test were not significantly different when comparing baseline with the case after treatment. However, because at both 1 and 2 hours the plasma glucose decreased with chromium but increased with placebo (i.e., the effect was in opposite directions), there was a significant difference for these parameters when comparing treatment effect (chromium vs. placebo; within-subject effects before vs. after treatment). Two patients (one in each treatment group) ovulated twice, and one patient from the placebo group ovulated once during the 4 months of the study. The remaining patients had no evidence of ovulation by basal body temperature chart or serum P. Therefore, of 24 possible ovulatory cycles in the chromium group (four cycles for six patients), 8% (2/24) were ovulatory; and of 16 possible ovulatory cycles in the placebo group (four cycles for four patients), 19% (3 of 16) were ovulatory. This difference was not statistically significant (P=.63). After 4 months’ treatment with chromium picolinate (200 μg/d orally), there were no significant differences in the primary outcome measures, namely ovulation rates and insulin sensitivity, in the PCOS patients studied. There was, however, a significant improvement in glucose tolerance at 1 and 2 hours. This improvement in plasma glucose is consistent with prior studies (18Anderson R.A. Polansky M.M. Bryden N.A. Canary J.J. Supplemental-chromium effects on glucose, insulin, glucagon, and urinary chromium losses in subjects consuming controlled low-chromium diets.Am J Clin Nutr. 1991; 54: 909-916PubMed Google Scholar, 19Anderson R.A. Cheng N. Bryden N.A. Polansky M.M. Chi J. Feng J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes.Diabetes. 1997; 46: 1786-1791Crossref PubMed Google Scholar, 21Anderson R.A. Chromium, glucose intolerance and diabetes.J Am Coll Nutr. 1998; 17: 548-555Crossref PubMed Scopus (372) Google Scholar). Although the plasma glucose after treatment did not change significantly from baseline, there were significant differences when comparing chromium with placebo. We believe that these differences in plasma glucose are caused by worsening of insulin resistance in the placebo group. Failure to show a significant effect of chromium picolinate on ovulation rate or insulin sensitivity in PCOS patients may be because of the short duration of the study (4 months), small treatment dose (200 μg/d), or small sample size. Prior studies have shown an effect after ≤4 months (18Anderson R.A. Polansky M.M. Bryden N.A. Canary J.J. Supplemental-chromium effects on glucose, insulin, glucagon, and urinary chromium losses in subjects consuming controlled low-chromium diets.Am J Clin Nutr. 1991; 54: 909-916PubMed Google Scholar, 19Anderson R.A. Cheng N. Bryden N.A. Polansky M.M. Chi J. Feng J. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes.Diabetes. 1997; 46: 1786-1791Crossref PubMed Google Scholar); however, the effect was greatest with 1,000 μg/d dosing. Assuming a 16% ovulation rate in the placebo group (22Goldzieher J. Green J. The polycystic ovary. I. Clinical and histologic features.J Clin Endocrinol Metab. 1962; 22: 325-338Crossref PubMed Scopus (272) Google Scholar) and an 80% ovulation rate in the chromium group, on the basis of studies with metformin (8Morin-Papunen L.C. Koivunen R.M. Ruokonen A. Martikainen H.K. Metformin therapy improves the menstrual pattern with minimal endocrine and metabolic effects in women with polycystic ovary syndrome.Fertil Steril. 1998; 69: 691-696Abstract Full Text Full Text PDF PubMed Scopus (262) Google Scholar, 9Nestler J.E. Jakubowicz D.J. Evans W.S. Pasquali R. Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome.N Engl J Med. 1998; 338: 1876-1880Crossref PubMed Scopus (717) Google Scholar) and with α = 0.05, we would need 10 patients in each group to achieve a power of 0.80. Smaller differences, as implied by this pilot study, would require larger sample sizes. This pilot study indicates that future studies in the PCOS population should examine higher dosages or longer durations of treatment. Future studies in the PCOS population may corroborate the positive effect that we saw on improved glucose tolerance. Additional findings may be discovered with a larger sample size, longer duration of treatment, or higher doses. Also, chromium picolinate may play a role as a supplement to treatment with other insulin sensitizers, which was not examined in the current study." @default.
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• W2093770110 date "2005-12-01" @default.
• W2093770110 modified "2023-09-30" @default.
• W2093770110 title "Effect of chromium supplementation on insulin resistance and ovarian and menstrual cyclicity in women with polycystic ovary syndrome" @default.
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• W2093770110 doi "https://doi.org/10.1016/j.fertnstert.2005.06.028" @default.
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