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Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00436865
First received: February 15, 2007
Last updated: December 10, 2015
Last verified: December 2015
  Purpose
The polycystic ovary syndrome is the leading cause of female infertility in the United States. The disorder affects approximately 6-10% of women of reproductive age. It is widely accepted that "insulin resistance" may be responsible for the infertility of this syndrome. Women are insulin resistant when their bodies do not respond to insulin's action to handle sugar as they normally should. Because of this insulin resistance, women with the polycystic ovary syndrome are also at high risk for developing type 2 diabetes. We have previously shown that D-chiro-inositol (DCI), a substance naturally found in our body that helps insulin's action, is lacking in women with the polycystic ovary syndrome. Not having enough DCI may lead to insulin resistance. The purpose of this study is to determine if weight loss helps to replenish the body with DCI and help to promote insulin's action.

Condition Intervention
Polycystic Ovary Syndrome
Obesity
Behavioral: Weight loss

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin and the Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Insulin sensitivity (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Changes of Serum D-Chiro-Inositol (DCI) concentrations (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Changes of DCI renal clearance (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Changes of AUC insulin during OGTT (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • AUC of bioactive DCI-IPG during OGTT (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Ratio of AUC DCI-IPG to AUC insulin during OGTT (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Serum Myo-Inositol (Myo) concentrations (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • MYO bioactivity (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Serum inflammatory and cardiovascular markers (Change from baseline to 8 weeks) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: February 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PCOS
PCOS women receiving weight loss intervention
Behavioral: Weight loss
Control
Non-PCOS women receiving weight loss intervention
Behavioral: Weight loss

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese (≥ 30 kg/m2) premenopausal women with PCOS and normal women between 18-40 years of age.
  • PCOS women only:

    • oligomenorrhea (<= 8 menstrual periods annually),
    • biochemical hyperandrogenemia (elevated total or free testosterone),
    • normal thyroid function tests and serum prolactin, and
    • exclusion of 21alpha-hydroxylase deficiency by a fasting 17alpha-hydroxyprogesterone <200 ng/dl.
  • Normal women only:

    • regular monthly menses, and
    • normal serum total and free testosterone.
  • All women:

    • acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis),
    • have not been dieting in the 3 months prior to study enrollment,
    • signed, witnessed informed consent,
    • ability to comply with study requirements.

Exclusion Criteria:

  • Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer).
  • Documented or suspected recent (within one year) history of drug abuse or alcoholism.
  • Ingestion of any investigational drug within 3 months prior to study onset.
  • Pregnancy as documented by urine hCG.
  • PCOS women only: Change in PCOS medication regimen (oral contraceptives, spironolactone, insulin sensitizers) within 3 months prior to the start of the study.
  • Normal women only:

    • history of gestational diabetes,
    • positive family history for first-degree relative with diabetes,
    • disorders linked to insulin resistance (hypertension or dyslipidemia),
    • Use of oral or other systemic contraceptives, or spironolactone within 3 months prior to the start of the study,
    • Use of medications (including OTC drugs) known to affect insulin sensitivity such as metformin, rosiglitazone, pioglitazone, niacin, corticosteroids, beta blockers, calcium channel blockers and thiazide diuretics within 3 months prior to the start of the study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436865

Locations
United States, Virginia
Virginia Commonwealth University General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Kai I. Cheang, Pharm.D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00436865     History of Changes
Other Study ID Numbers: K23HD049454-01A2 
Study First Received: February 15, 2007
Last Updated: December 10, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 08, 2016