Insulin and the Polycystic Ovary Syndrome--Weight Reduction Study

NCT00436865 | Completed

• 2 other identifiers: HM10313K23HD049454-01A2
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Obesity

Outcome Measures

Primary Outcomes (6)

• Insulin sensitivity (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• Changes of Serum D-Chiro-Inositol (DCI) concentrations (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• Changes of DCI renal clearance (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• Changes of AUC insulin during OGTT (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• AUC of bioactive DCI-IPG during OGTT (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• Ratio of AUC DCI-IPG to AUC insulin during OGTT (Change from baseline to 8 weeks)

  Baseline to 8 weeks

Secondary Outcomes (4)

• Weight loss (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• Serum Myo-Inositol (Myo) concentrations (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• MYO bioactivity (Change from baseline to 8 weeks)

  Baseline to 8 weeks

• Serum inflammatory and cardiovascular markers (Change from baseline to 8 weeks)

  Baseline to 8 weeks

Study Arms (2)

PCOS

OTHER

PCOS women receiving weight loss intervention

Behavioral: Weight loss

Control

OTHER

Non-PCOS women receiving weight loss intervention

Behavioral: Weight loss

Interventions

Weight loss BEHAVIORAL

Control; PCOS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Virginia Commonwealth University General Clinical Research Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kai I. Cheang, Pharm.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

US (1)