Clinical Trial: Meal Timing on Glucose and Hyperandrogenism in PCOS Women

Study Status: Active, not recruiting
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:

The objective of this study is to investigate the effects of two isocaloric maintenance diets with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome P450c17 alpha activity in lean PCOS women.

The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.


Detailed Summary:

Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS women. These women are insulin resistant and have compensatory hyperinsulinemia that stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian androgen concentrations.

In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms.

Since lean PCOS women do not have the option of weight loss, it is important to know if composition and meal timing distribution may influence glucose metabolism and hyperandrogenism and cytochrome P450c17 alpha activity. 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


Sponsor: Hospital de Clinicas Caracas

Current Primary Outcome: Changes in Androgens and 17 alpha hydroxyprogesterone serum levels [ Time Frame: 90 days ]

The androgens (testosterone, free testosterone, DHEA-S, androstenedione)and 17 alpha hydroxyprogesterone will be measured at baseline and again will be measured at the end of the trial by day 90. In both groups or Arms one on breakfast diet and the other on dinner diet.


Original Primary Outcome: Changes in Androgen serum levels [ Time Frame: 90 days ]

The androgens (testosterone, free testosterone, DHEA-s, androstenediones) will be measured at baseline and again will be measured at the end of the trial by day 90. in both groups or Armas one on breakfast diet and the other on dinner diet.


Current Secondary Outcome: Glucose and Insulin Response to OGTT [ Time Frame: 90 ]

Glucose and Insulin Response to OGTT will be measured at baseline and again will be repeated after 90 days of the trial for comparison One group will be assigned to breakfast diet and the other group to dinner diet


Original Secondary Outcome: Glucose and Insulin Response to OGTT [ Time Frame: 90 ]

Glucose and Insulin Response to OGTT will be measured at baseline and again will be repeated after 90 day of the trial for comparison One grou will be assigned to breakfast diet and the other group to dinner diet


Information By: Hospital de Clinicas Caracas

Dates:
Date Received: October 17, 2012
Date Started: October 2012
Date Completion: January 2013
Last Updated: January 20, 2013
Last Verified: January 2013