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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hospital de Clinicas Caracas
Sponsor:
Information provided by (Responsible Party):
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier:
NCT01711476
First received: October 17, 2012
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome (PCOS) Women
Behavioral: Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2
Other: Active Comparator: Lifestyle counseling ARM 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas Caracas:

Primary Outcome Measures:
  • Changes in Androgens and 17 alpha hydroxyprogesterone serum levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Ovulatory frequency [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: The lean PCOS patients assigned to dinner diet

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

  Eligibility

Ages Eligible for Study:   22 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711476

Contacts
Contact: Daniela Jakubowicz, MD 582123355075 daniela.jak@gmail.com

Locations
Venezuela
Daniela Jakubowicz Recruiting
Caracas, San Bernardino, Venezuela, 410
Principal Investigator: Daniela Jakubowicz, MD         
Sponsors and Collaborators
Hospital de Clinicas Caracas
Investigators
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
  More Information

No publications provided

Responsible Party: Daniela Jakubowicz, MD, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier: NCT01711476     History of Changes
Other Study ID Numbers: HCCCBI 018-2008-104
Study First Received: October 17, 2012
Last Updated: January 20, 2013
Health Authority: Venezuela: Ethics Committee

Keywords provided by Hospital de Clinicas Caracas:
PCOS
Bdiet
Ddiet
OGTT

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Hyperandrogenism
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 01, 2014