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

Primary Purpose

Polycystic Ovary Syndrome (PCOS) Women

Status
Unknown status
Phase
Not Applicable
Locations
Venezuela
Study Type
Interventional
Intervention
Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2
Active Comparator: Lifestyle counseling ARM 1
Sponsored by
Hospital de Clinicas Caracas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) Women focused on measuring PCOS, Bdiet, Ddiet, OGTT

Eligibility Criteria

22 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Daniela JakubowiczRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lifestyle counseling ARM 1

Lifestyle counseling ARM 2

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Glucose and Insulin Response to OGTT
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

Full Information

First Posted
October 17, 2012
Last Updated
January 20, 2013
Sponsor
Hospital de Clinicas Caracas
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1. Study Identification

Unique Protocol Identification Number
NCT01711476
Brief Title
Meal Timing on Glucose and Hyperandrogenism in PCOS Women
Acronym
MealTimePCOS
Official Title
Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas Caracas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS) Women
Keywords
PCOS, Bdiet, Ddiet, OGTT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling ARM 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Lifestyle counseling ARM 2
Arm Type
Placebo Comparator
Arm Description
Lean PCOS women in the Arm 2 will be assigned to do a dinner diet from day 0 to day 90 of the trial
Intervention Type
Behavioral
Intervention Name(s)
Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2
Other Intervention Name(s)
The lean PCOS patients assigned to dinner diet
Intervention Description
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
Other
Intervention Name(s)
Active Comparator: Lifestyle counseling ARM 1
Other Intervention Name(s)
Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Androgens and 17 alpha hydroxyprogesterone serum levels
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Glucose and Insulin Response to OGTT
Description
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
Time Frame
90
Other Pre-specified Outcome Measures:
Title
Ovulatory frequency
Description
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)
Time Frame
90 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Jakubowicz, MD
Phone
582123355075
Email
daniela.jak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Organizational Affiliation
Hospital de Clinicas Caracas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daniela Jakubowicz
City
Caracas
State/Province
San Bernardino
ZIP/Postal Code
410
Country
Venezuela
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD

12. IPD Sharing Statement

Learn more about this trial

Meal Timing on Glucose and Hyperandrogenism in PCOS Women

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