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)...
Brief Summary
Official Title: “Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives”
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: May 2012
Detailed Clinical Trial Description
The purpose of this study is to:
1) 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.
Intervention(s) in this Clinical Trial
- Drug: rosiglitazone
- 4 mg daily for 6 months
- Drug: drospirenone/ethinyl estradiol
- 1 tab (3mg/30mcg) daily for 6 months
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Rosiglitazone
- Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
- Active Comparator: Drospirenone/ethinyl estradiol
- Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
- No Intervention: Overweight/Obese without PCOS
- Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
- No Intervention: Lean without PCOS
- Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
Outcome Measures for this Clinical Trial
Primary Measures
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance.
- Time Frame: 6 months
Safety Issue?: Yes
- Time Frame: 6 months
Secondary Measures
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on bone turnover
- Time Frame: 6 months
Safety Issue?: Yes
- Time Frame: 6 months
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism
- Time Frame: 6 months
Safety Issue?: Yes
- Time Frame: 6 months
- To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on cardiovascular health and inflammation
- Time Frame: 6 months
Safety Issue?: Yes
- Time Frame: 6 months
- To compare the markers of cardiovascular health and inflammation within the PCOS group to those in overweight females without PCOS and lean females without PCOS
- Time Frame: Baseline
Safety Issue?: No
- Time Frame: Baseline
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 10 Years
Maximum Age for this Clinical Trial: 20 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Children's Hospital of Pittsburgh Other
Overall Clinical Trial Officials and Contacts
Silva Arslanian, M.D. Principal Investigator University of Pittsburgh
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640224
Study ID Number: 0503013
ClinicalTrials.gov Identifier: NCT00640224
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00640224
