Meal Timing on Glucose and Hyperandrogenism in PCOS Women

NCT01711476 | Unknown DMC

• 1 other identifier: HCCCBI 018-2008-104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome (PCOS) Women

Keywords

PCOS; Bdiet; Ddiet; OGTT

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (1)

• Glucose and Insulin Response to OGTT

  90

Other Outcomes (1)

• Ovulatory frequency

  90 days

Study Arms (2)

Lifestyle counseling ARM 1

ACTIVE COMPARATOR

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

Lifestyle counseling ARM 2

PLACEBO COMPARATOR

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

Interventions

Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2 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

Also known as: The lean PCOS patients assigned to dinner diet

Lifestyle counseling ARM 2

Active Comparator: Lifestyle counseling ARM 1 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

Also known as: Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study

Lifestyle counseling ARM 1

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like hypothyroidism, late onset adrenal hyperplasia Pregnancy Contraceptive or other hormonal treatment

Sponsors & Collaborators

• Hospital de Clinicas Caracas: lead

Study Sites (1)

Daniela Jakubowicz

Caracas, San Bernardino, 410, Venezuela

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Daniela Jakubowicz, MD

  Hospital de Clinicas Caracas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Jakubowicz, MD

CONTACT

582123355075; daniela.jak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

VE (1)