Clinical trial NCT00640224: Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Official title: Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-03-21
Enrollment: 65
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Peripheral Insulin Sensitivity at Baseline and 6 Months.
timeFrame: Baseline and 6 months
measure: Hepatic Insulin Sensitivity at Baseline and 6 Months.
timeFrame: Baseline and 6 months
measure: Glucose Tolerance Status at Baseline and 6 Months.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Total Fat Mass at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Total Testosterone at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Percent Body Fat at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Free Testosterone at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: SHBG at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: DHEAS at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Delta Androstenedione at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Delta DHEA at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Delta 17-OHProg at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Delta 17-OHPreg at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Cholesterol at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: HDL at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: LDL at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Triglycerides at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Non-HDL Cholesterol at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Adiponectin at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Leptin at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Hs-CRP at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Morning Blood Pressure at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Night Blood Pressure at Baseline and 6 Months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Silva Arslanian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tfayli H, Ulnach JW, Lee S, Sutton-Tyrrell K, Arslanian S. Drospirenone/ethinyl estradiol versus rosiglitazone treatment in overweight adolescents with polycystic ovary syndrome: comparison of metabolic, hormonal, and cardiovascular risk factors. J Clin Endocrinol Metab. 2011 May;96(5):1311-9. doi: 10.1210/jc.2010-2547. Epub 2011 Feb 16.