Clinical Trial: Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome

Brief Summary: In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may have clinical value. In this study the investigators investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.

Detailed Summary:

Insulin resistance and hyperinsulinemia plays a pivotal role in the pathogenesis of polycystic ovary syndrome (PCOS). Hyperinsulinemia stimulates ovarian cytochrome P450c17 alpha activity, in obese and nonobese women with PCOS, thereby increasing serum levels of 17-alpha-hydroxyprogesterone, androgens concentrations, decreasing SHBG and promoting the clinical features of hyperandrogenism.

In women with PCOS, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Since lean women with PCOS do not have the option of weight loss, it is important to know weather diet composition and meal timing distribution may influence glucose metabolism and hyperandrogenism.

We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS.

Objective:The objective of this study is to investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS women.


Sponsor: Tel Aviv University

Current Primary Outcome: hyperandrogenism [ Time Frame: 90 days ]

Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution


Original Primary Outcome: Same as current

Current Secondary Outcome: glucose metabolism [ Time Frame: 90 days ]

Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution


Original Secondary Outcome: Same as current

Information By: Tel Aviv University

Dates:
Date Received: March 30, 2012
Date Started: March 2012
Date Completion: June 2015
Last Updated: April 7, 2015
Last Verified: April 2015