Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Changes in Androgens and 17 alpha hydroxyprogesterone serum levels
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.
90 days
No
Daniela Jakubowicz, MD
Principal Investigator
Hospital de Clinicas Caracas
Venezuela: Ethics Committee
HCCCBI 018-2008-104
NCT01711476
October 2012
January 2013
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