Meal Timing on Glucose and Hyperandrogenism in PCOS Women

NCT ID: NCT01711476

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-01-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling ARM 1

Arm 1 Breakfast Diet The arm 1 will be assigned to eat High calorie breakfast (800kcal) and reduced dinner (200 kcal) During 90 days from baseline to the end of the trial (day 90)

Group Type: ACTIVE_COMPARATOR

Active Comparator: Lifestyle counseling ARM 1

Intervention Type: OTHER

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

Lifestyle counseling ARM 2

Lean PCOS women in the Arm 2 will be assigned to do a dinner diet from day 0 to day 90 of the trial

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Other Intervention Names

The lean PCOS patients assigned to dinner diet; Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas Caracas

OTHER

Sponsor Role: lead

Responsible Party

Daniela Jakubowicz, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Jakubowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas Caracas

Locations

Daniela Jakubowicz

Caracas, San Bernardino, Venezuela

Site Status: RECRUITING

Countries

Venezuela

Central Contacts

Daniela Jakubowicz, MD

Role: CONTACT

daniela.jak@gmail.com

582123355075

Other Identifiers

HCCCBI 018-2008-104

Identifier Type: -

Identifier Source: org_study_id