Meal Timing on Glucose and Hyperandrogenism in PCOS Women (MealTimePCOS)

January 20, 2013 updated by: Daniela Jakubowicz, MD, Hospital de Clinicas Caracas

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Venezuela
    • San Bernardino
      • Caracas, San Bernardino, Venezuela, 410
        • Recruiting
        • Daniela Jakubowicz
        • Principal Investigator:
          • Daniela Jakubowicz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
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
Other Names:
  • Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study
Placebo Comparator: 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
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 Names:
  • The lean PCOS patients assigned to dinner diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulatory frequency
Time Frame: 90 days
From baseline (day O) to the end of the study (day 90) progesterone will be quantified weekly to assess the ovulation in both of the group (The ovulation in the breakfast diet group will be compared to that of the dinner diet group)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas Caracas

Investigators

  • Principal Investigator: Daniela Jakubowicz, MD, Hospital de Clínicas Caracas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 20, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCCCBI 018-2008-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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