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


Phase 4
10 Years
20 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance.

Outcome Description:

Insulin resistance will be assessed by the hyperinsulinemic-euglycemic clamp. In addition glucose tolerance will be assessed using an oral glucose tolerance test

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Silva Arslanian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

0503013

NCT ID:

NCT00640224

Start Date:

March 2005

Completion Date:

December 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Polycystic Ovary Syndrome

Name

Location

Children's HospitalPhiladelphia, Pennsylvania