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Parent Study stopped due to poor recruitment and enrollment
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The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).
Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polycystic Ovary Syndrome | Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusiveBody mass index ≥ 25kg/m2History of irregular menstrual cycles (fewer than 8 regular cycles in the past year)Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)Anovulatory menstrual cycles (determined during screening) |
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| Measure | Description | Time Frame |
|---|---|---|
| Bio specimens for future research | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Overweight women with polycystic ovary syndrome.
20 - 40 years, inclusive Body mass index ≥ 25kg/m2 History of irregular menstrual cycles (fewer than 8 regular cycles in the past year) Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8) Anovulatory menstrual cycles (determined during screening)
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D001835 | Body Weight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Skeletal Muscle Subcutaneous Adipose Tissue
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |