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Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640224
First Posted: March 21, 2008
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Silva Arslanian, University of Pittsburgh
  Purpose
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).

Condition Intervention Phase
Polycystic Ovary Syndrome Drug: rosiglitazone Drug: drospirenone/ethinyl estradiol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

Resource links provided by NLM:


Further study details as provided by Silva Arslanian, University of Pittsburgh:

Primary Outcome Measures:
  • Peripheral Insulin Sensitivity at Baseline and 6 Months. [ Time Frame: Baseline and 6 months ]
    Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.

  • 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.


Secondary Outcome Measures:
  • Total Fat Mass at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.

  • Total Testosterone at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.

  • Percent Body Fat at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    DXA scans were done to measure the percentage of body fat.

  • Free Testosterone at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Free testosterone was measured by equilibrium dialysis.

  • SHBG at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.

  • DHEAS at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.

  • Delta Androstenedione at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.

  • Delta DHEA at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta DHEA was measured by HPLC-tandem mass spectroscopy.

  • Delta 17-OHProg at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.

  • Delta 17-OHPreg at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.

  • Cholesterol at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.

  • HDL at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.

  • LDL at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.

  • Triglycerides at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.

  • Non-HDL Cholesterol at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.

  • Adiponectin at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Adiponectin was measured by radioimmunoassay.

  • Leptin at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Leptin was measured by radioimmunoassay.

  • Hs-CRP at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.

  • Morning Blood Pressure at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Morning blood pressure was measured with an automated sphygmomanometer.

  • Night Blood Pressure at Baseline and 6 Months [ Time Frame: Baseline and 6 months ]
    Night blood pressure was measured with an automated sphygmomanometer.


Enrollment: 65
Study Start Date: March 2005
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosiglitazone
Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
Drug: rosiglitazone
4 mg daily for 6 months
Other Name: Avandia
Active Comparator: Drospirenone/ethinyl estradiol
Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
Drug: drospirenone/ethinyl estradiol
1 tab (3mg/30mcg) daily for 6 months
Other Name: Yasmin
No Intervention: Overweight/Obese without PCOS
Overweight adolescent females without PCOS to use as comparison of normal developmental changes. *No participants were enrolled in this Arm.
No Intervention: Lean without PCOS
Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. *No participants were enrolled in this Arm.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640224


Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Silva Arslanian
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Silva Arslanian, M.D. University of Pittsburgh
  More Information

Publications:
Responsible Party: Silva Arslanian, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00640224     History of Changes
Other Study ID Numbers: 0503013
2K24HD001357 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2008
First Posted: March 21, 2008
Results First Submitted: July 27, 2017
Results First Posted: November 16, 2017
Last Update Posted: November 16, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Rosiglitazone
Insulin
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Drospirenone and ethinyl estradiol combination
Hypoglycemic Agents
Physiological Effects of Drugs
Estrogens
Hormones