Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640224
• Other study ID #: 0503013
• Secondary ID: 2K24HD001357
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: October 16, 2017
• Start date: March 2005
• Est. completion date: July 2015

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• rosiglitazone
4 mg daily for 6 months
• drospirenone/ethinyl estradiol
1 tab (3mg/30mcg) daily for 6 months

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Silva Arslanian	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral Insulin Sensitivity at Baseline and 6 Months.	Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.	Baseline and 6 months
Primary	Hepatic Insulin Sensitivity at Baseline and 6 Months.	Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.	Baseline and 6 months
Primary	Glucose Tolerance Status at Baseline and 6 Months.	Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.	Baseline and 6 months
Secondary	Total Fat Mass at Baseline and 6 Months	DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.	Baseline and 6 months
Secondary	Total Testosterone at Baseline and 6 Months	Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.	Baseline and 6 months
Secondary	Percent Body Fat at Baseline and 6 Months	DXA scans were done to measure the percentage of body fat.	Baseline and 6 months
Secondary	Free Testosterone at Baseline and 6 Months	Free testosterone was measured by equilibrium dialysis.	Baseline and 6 months
Secondary	SHBG at Baseline and 6 Months	SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.	Baseline and 6 months
Secondary	DHEAS at Baseline and 6 Months	DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.	Baseline and 6 months
Secondary	Delta Androstenedione at Baseline and 6 Months	Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.	Baseline and 6 months
Secondary	Delta DHEA at Baseline and 6 Months	Delta DHEA was measured by HPLC-tandem mass spectroscopy.	Baseline and 6 months
Secondary	Delta 17-OHProg at Baseline and 6 Months	Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.	Baseline and 6 months
Secondary	Delta 17-OHPreg at Baseline and 6 Months	Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.	Baseline and 6 months
Secondary	Cholesterol at Baseline and 6 Months	Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.	Baseline and 6 months
Secondary	HDL at Baseline and 6 Months	HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.	Baseline and 6 months
Secondary	LDL at Baseline and 6 Months	LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.	Baseline and 6 months
Secondary	Triglycerides at Baseline and 6 Months	Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.	Baseline and 6 months
Secondary	Non-HDL Cholesterol at Baseline and 6 Months	Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.	Baseline and 6 months
Secondary	Adiponectin at Baseline and 6 Months	Adiponectin was measured by radioimmunoassay.	Baseline and 6 months
Secondary	Leptin at Baseline and 6 Months	Leptin was measured by radioimmunoassay.	Baseline and 6 months
Secondary	Hs-CRP at Baseline and 6 Months	hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.	Baseline and 6 months
Secondary	Morning Blood Pressure at Baseline and 6 Months	Morning blood pressure was measured with an automated sphygmomanometer.	Baseline and 6 months
Secondary	Night Blood Pressure at Baseline and 6 Months	Night blood pressure was measured with an automated sphygmomanometer.	Baseline and 6 months