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

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ClinicalTrials.gov Identifier: NCT01711476
Recruitment Status : Unknown
Verified January 2013 by Daniela Jakubowicz, MD, Hospital de Clinicas Caracas.
Recruitment status was:  Recruiting
First Posted : October 22, 2012
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas

Tracking Information
First Submitted Date  ICMJE October 17, 2012
First Posted Date  ICMJE October 22, 2012
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
Changes in Androgen serum levels [ Time Frame: 90 days ]
The androgens (testosterone, free testosterone, DHEA-s, androstenediones) will be measured at baseline and again will be measured at the end of the trial by day 90. in both groups or Armas one on breakfast diet and the other on dinner diet.
Change History Complete list of historical versions of study NCT01711476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
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 day of the trial for comparison One grou will be assigned to breakfast diet and the other group to dinner diet
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2013)
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)
Original Other Pre-specified Outcome Measures
 (submitted: October 18, 2012)
Ovulatory frequency [ Time Frame: 90 days ]
From baseline ( day O) to the and 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)
 
Descriptive Information
Brief Title  ICMJE Meal Timing on Glucose and Hyperandrogenism in PCOS Women
Official Title  ICMJE Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome (PCOS) Women
Intervention  ICMJE
  • 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 Name: The lean PCOS patients assigned to 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
    Other Name: Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study
Study Arms  ICMJE
  • 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)
    Intervention: Other: Active Comparator: Lifestyle counseling ARM 1
  • 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
    Intervention: Behavioral: Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 18, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 22 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01711476
Other Study ID Numbers  ICMJE HCCCBI 018-2008-104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
Study Sponsor  ICMJE Hospital de Clinicas Caracas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
PRS Account Hospital de Clinicas Caracas
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP