Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Hepatic Insulin Sensitivity at Baseline and 6 Months.
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 20 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Rosiglitazone
Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
Intervention: rosiglitazone (Drug)
Drospirenone/ethinyl estradiol
Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
Intervention: drospirenone/ethinyl estradiol (Drug)
Outcomes
Primary Outcomes
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.
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.
Peripheral Insulin Sensitivity at Baseline and 6 Months.
Time Frame: Baseline and 6 months
Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
Secondary Outcomes
- LDL at Baseline and 6 Months(Baseline and 6 months)
- Delta Androstenedione at Baseline and 6 Months(Baseline and 6 months)
- Delta DHEA at Baseline and 6 Months(Baseline and 6 months)
- Cholesterol at Baseline and 6 Months(Baseline and 6 months)
- SHBG at Baseline and 6 Months(Baseline and 6 months)
- Delta 17-OHPreg at Baseline and 6 Months(Baseline and 6 months)
- Non-HDL Cholesterol at Baseline and 6 Months(Baseline and 6 months)
- Leptin at Baseline and 6 Months(Baseline and 6 months)
- Total Testosterone at Baseline and 6 Months(Baseline and 6 months)
- Adiponectin at Baseline and 6 Months(Baseline and 6 months)
- Hs-CRP at Baseline and 6 Months(Baseline and 6 months)
- Total Fat Mass at Baseline and 6 Months(Baseline and 6 months)
- Percent Body Fat at Baseline and 6 Months(Baseline and 6 months)
- DHEAS at Baseline and 6 Months(Baseline and 6 months)
- Morning Blood Pressure at Baseline and 6 Months(Baseline and 6 months)
- Free Testosterone at Baseline and 6 Months(Baseline and 6 months)
- Delta 17-OHProg at Baseline and 6 Months(Baseline and 6 months)
- HDL at Baseline and 6 Months(Baseline and 6 months)
- Triglycerides at Baseline and 6 Months(Baseline and 6 months)
- Night Blood Pressure at Baseline and 6 Months(Baseline and 6 months)
Investigators
Silva Arslanian
Principal Investigator
University of Pittsburgh