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Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome (M-PCOS)

Primary Purpose

Hyperandrogenism, Insulin Resistance

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Dietary intervention

About this trial

This is an interventional supportive care trial for Hyperandrogenism focused on measuring PCOS

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subjects ≥18 and ≤45 years of age
Lean women with PCOS (BMI: ≤ 25 kg/m2)
Signed informed consent
Exclusion of late-onset adrenal hyperplasia by a fasting serum 17- hydroxy progesterone concentration below 200 ng/dl.
Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC).
Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
Stable physical activity pattern during the three months immediately preceding study initiation
Hyperandrogenemia (elevated free testosterone).
Normal liver and kidney function
Fasting blood glucose <110 mg/dl.
No metabolic disease
Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
Normal TSH and FT4 levels and serum prolactin
Acceptable health based on interview, medical history, physical examination, and laboratory tests

Exclusion Criteria:

Diabetes mellitus diagnosed by fasting glucose or a 2-hour OGTT, or fasting glucose > 110 mg/dl
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease (other than skin cancer).
Current use of oral contraceptives
Serum creatinine level > 1.5 mg/dl
Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
Any physiologic or mechanical problems preventing dietary adherence
Pregnant or lactating
Participating in another dietary program or use of weight-loss medications
Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
Use of psychotropic or anoretic medication during the month immediately prior to study onset
Night or rotating shift work
Jet lag during the 2 week period immediately prior to study onset
-

Sites / Locations

Daniela Jakubowicz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle counseling

Life Counseling

Arm Description

Lifestyle counseling, with high calorie breakfast

Diet with high calorie dinner

Outcomes

Primary Outcome Measures

hyperandrogenism

Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution

Secondary Outcome Measures

glucose metabolism

Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution

Full Information

NCT ID

NCT01569425

First Posted

March 30, 2012

Last Updated

April 7, 2015

Sponsor

Tel Aviv University

1. Study Identification

Unique Protocol Identification Number

NCT01569425

Brief Title

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

Acronym

M-PCOS

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

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tel Aviv University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may have clinical value. In this study the investigators investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.

Detailed Description

Insulin resistance and hyperinsulinemia plays a pivotal role in the pathogenesis of polycystic ovary syndrome (PCOS). Hyperinsulinemia stimulates ovarian cytochrome P450c17 alpha activity, in obese and nonobese women with PCOS, thereby increasing serum levels of 17-alpha-hydroxyprogesterone, androgens concentrations, decreasing SHBG and promoting the clinical features of hyperandrogenism. In women with PCOS, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Since lean women with PCOS do not have the option of weight loss, it is important to know weather diet composition and meal timing distribution may influence glucose metabolism and hyperandrogenism. 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. Objective:The objective of this study is to investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperandrogenism, Insulin Resistance

Keywords

PCOS

7. Study Design

Primary Purpose

Supportive Care

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 Type

Experimental

Arm Description

Lifestyle counseling, with high calorie breakfast

Arm Title

Life Counseling

Arm Type

Active Comparator

Arm Description

Diet with high calorie dinner

Intervention Type

Other

Intervention Name(s)

Dietary intervention

Intervention Description

High Calorie breakfast and high calorie dinner

Primary Outcome Measure Information:

Title

hyperandrogenism

Description

Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution

Time Frame

90 days

Secondary Outcome Measure Information:

Title

glucose metabolism

Description

Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution

Time Frame

90 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects ≥18 and ≤45 years of age Lean women with PCOS (BMI: ≤ 25 kg/m2) Signed informed consent Exclusion of late-onset adrenal hyperplasia by a fasting serum 17- hydroxy progesterone concentration below 200 ng/dl. Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC). Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months Stable physical activity pattern during the three months immediately preceding study initiation Hyperandrogenemia (elevated free testosterone). Normal liver and kidney function Fasting blood glucose <110 mg/dl. No metabolic disease Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00. Normal TSH and FT4 levels and serum prolactin Acceptable health based on interview, medical history, physical examination, and laboratory tests Exclusion Criteria: Diabetes mellitus diagnosed by fasting glucose or a 2-hour OGTT, or fasting glucose > 110 mg/dl Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease (other than skin cancer). Current use of oral contraceptives Serum creatinine level > 1.5 mg/dl Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate Any physiologic or mechanical problems preventing dietary adherence Pregnant or lactating Participating in another dietary program or use of weight-loss medications Documented or suspected history (within one year) of illicit drug abuse or alcoholism. Use of psychotropic or anoretic medication during the month immediately prior to study onset Night or rotating shift work Jet lag during the 2 week period immediately prior to study onset -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniela Jakubowicz, MD

Organizational Affiliation

Diabetes Unit E. Wolfson Medical Center Tel Aviv University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mona Boaz, PhD

Organizational Affiliation

E. Wolfson Medical Center Tel Aviv University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Julio Wainstein, MD

Organizational Affiliation

E. Wolfson Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Daniela Jakubowicz

City

Holon

State/Province

Tel Aviv

ZIP/Postal Code

58100

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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