Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study - Full Text View

Sponsor:	Children's Hospital of Pittsburgh
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):	Silva Arslanian, M.D., Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00640224

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Children's Hospital of Pittsburgh:

Primary Outcome Measures:

To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Insulin resistance will be assessed by the hyperinsulinemic-euglycemic clamp. In addition glucose tolerance will be assessed using an oral glucose tolerance test

Secondary Outcome Measures:

To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on bone turnover [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
DXA scans and bone turnover markers will be measured at baseline and at completion of the study
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Hyperandrogenism will be assessed by measuring testosterone level, and the response to a cortrosyn stimulation test at baseline and at completion of the study.
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on cardiovascular health and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Lipid profiles,cardiovascular markers, intima media thickness, pulse wave velocity, and coronary califications using an EBCT will bemeasured at baseline and at conclusion of the study
To compare the markers of cardiovascular health and inflammation within the PCOS group to those in overweight females without PCOS and lean females without PCOS [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	May 2012 (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 Intervention: Lean without PCOS Lean healthy girls without PCOS to serve as controls for the cardiovascular markers

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

Ages Eligible for Study:	10 Years to 20 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640224

Locations

United States, Pennsylvania
Children's Hospital
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Children's Hospital of Pittsburgh

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Silva Arslanian, M.D.

University of Pittsburgh

More Information

No publications provided by Children's Hospital of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Feb 16.

Responsible Party:	Silva Arslanian, M.D., Principal Investigator, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00640224 History of Changes
Other Study ID Numbers:	0503013, 2K24HD001357
Study First Received:	March 18, 2008
Last Updated:	February 8, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Contraceptives, Oral
Estradiol

Polyestradiol phosphate
Ethinyl Estradiol
Drospirenone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Rosiglitazone
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens

ClinicalTrials.gov processed this record on February 09, 2012