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Completed

NCT Number: NCT00640224

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

10 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

About this study

The purpose of this study is to:

  • to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10 - 20 years
  • Pubertal level of Tanner stage III-V and menarchal
  • BMI percentile for age and sex greater than or equal to 85%ile

Exclusion criteria

  • Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
  • Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
  • Established diagnosis of diabetes
  • Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
  • Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
  • Vitamin D deficiency (<10ng/mL)
  • Hyperkalemia (K>5.0 meq/L)
  • Positive pregnancy test (serum)

Treatment and study plan

rosiglitazone

Drug

4 mg daily for 6 months

Other names: Avandia

Drospirenone/Ethinyl Estradiol

Drug

1 tab (3mg/30mcg) daily for 6 months

Other names: Yasmin

Primary outcomes

  1. Peripheral Insulin Sensitivity at Baseline and 6 Months.

    Time frame: Baseline and 6 months

    Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.

  2. Hepatic Insulin Sensitivity at Baseline and 6 Months.

    Time frame: Baseline and 6 months

    Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.

  3. Glucose Tolerance Status at Baseline and 6 Months.

    Time frame: Baseline and 6 months

    Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.

Secondary outcomes

  1. Total Fat Mass at Baseline and 6 Months

    Time frame: Baseline and 6 months

    DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.

  2. Total Testosterone at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.

  3. Percent Body Fat at Baseline and 6 Months

    Time frame: Baseline and 6 months

    DXA scans were done to measure the percentage of body fat.

  4. Free Testosterone at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Free testosterone was measured by equilibrium dialysis.

  5. SHBG at Baseline and 6 Months

    Time frame: Baseline and 6 months

    SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.

  6. DHEAS at Baseline and 6 Months

    Time frame: Baseline and 6 months

    DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.

  7. Delta Androstenedione at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.

  8. Delta DHEA at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Delta DHEA was measured by HPLC-tandem mass spectroscopy.

  9. Delta 17-OHProg at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.

  10. Delta 17-OHPreg at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.

  11. Cholesterol at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.

  12. HDL at Baseline and 6 Months

    Time frame: Baseline and 6 months

    HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.

  13. LDL at Baseline and 6 Months

    Time frame: Baseline and 6 months

    LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.

  14. Triglycerides at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.

  15. Non-HDL Cholesterol at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.

  16. Adiponectin at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Adiponectin was measured by radioimmunoassay.

  17. Leptin at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Leptin was measured by radioimmunoassay.

  18. Hs-CRP at Baseline and 6 Months

    Time frame: Baseline and 6 months

    hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.

  19. Morning Blood Pressure at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Morning blood pressure was measured with an automated sphygmomanometer.

  20. Night Blood Pressure at Baseline and 6 Months

    Time frame: Baseline and 6 months

    Night blood pressure was measured with an automated sphygmomanometer.

Sponsors and collaborators

Lead sponsor

Silva Arslanian

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Mar 21, 2008
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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