NCT01711476

Meal Timing on Glucose and Hyperandrogenism in PCOS Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospital de Clinicas Caracas · Academic / Other
• Sex: Female
• Age: 22 Years – 50 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Polycystic Ovary Syndrome (PCOS) Women

Interventions

Type	Name	Description
BEHAVIORAL	Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2	In this Arm 2 group the PCOS will be assigned to dinner diet and we will compare the androgen levels Day 0 to androgen after DAY 90 of this diet also we will compare Glucose and Insulin response to OGTT Day 0 and Day 90, and ovulatory frequency along alll the 90 days of the Dinner diet
OTHER	Active Comparator: Lifestyle counseling ARM 1	In the Arm 1 we will measure androgen levels and insulin and glucose response to OGTT at baseline DAY 0 and after 90 days on the dinner diet (Day 90) for comparison Also we will evaluate by weekly progesterone the ovulatory events

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-10-22
• Last updated: 2013-01-23

Locations

1 site across 1 country: Venezuela