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

22 Years
50 Years
Open (Enrolling)
Polycystic Ovary Syndrome (PCOS) Women

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Trial Information

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

Inclusion Criteria:

lean women with Polycystic Ovary BMI below 25 kg/m2 Testosterone above 1.0 ng/ml 17 Oh
progesterone below 200 ng/ml US of Polycystic Ovaries

Exclusion Criteria:

Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like
hypothyroidism, late onset adrenal hyperplasia Pregnancy Contraceptive or other
hormonal treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in Androgens and 17 alpha hydroxyprogesterone serum levels

Outcome Description:

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.

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Daniela Jakubowicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital de Clinicas Caracas


Venezuela: Ethics Committee

Study ID:

HCCCBI 018-2008-104



Start Date:

October 2012

Completion Date:

January 2013

Related Keywords:

  • Polycystic Ovary Syndrome (PCOS) Women
  • PCOS
  • Bdiet
  • Ddiet
  • OGTT
  • Polycystic Ovary Syndrome
  • Hyperandrogenism