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

NCT ID: NCT01569425

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Hyperandrogenism; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

Lifestyle counseling, with high calorie breakfast

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

High Calorie breakfast and high calorie dinner

Life Counseling

Diet with high calorie dinner

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: OTHER

High Calorie breakfast and high calorie dinner

Interventions

Dietary intervention

High Calorie breakfast and high calorie dinner

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects ≥18 and ≤45 years of age

2. Lean women with PCOS (BMI: ≤ 25 kg/m2)

3. Signed informed consent

4. Exclusion of late-onset adrenal hyperplasia by a fasting serum 17- hydroxy progesterone concentration below 200 ng/dl.

5. Acceptable health based on interview, medical history, physical examination, and laboratory tests (SMA20 and CBC).

6. Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months

7. Stable physical activity pattern during the three months immediately preceding study initiation

8. Hyperandrogenemia (elevated free testosterone).

9. Normal liver and kidney function

10. Fasting blood glucose <110 mg/dl.

11. No metabolic disease

12. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.

13. Normal TSH and FT4 levels and serum prolactin

14. Acceptable health based on interview, medical history, physical examination, and laboratory tests

Exclusion Criteria

1. Diabetes mellitus diagnosed by fasting glucose or a 2-hour OGTT, or fasting glucose > 110 mg/dl

2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease (other than skin cancer).

3. Current use of oral contraceptives

4. Serum creatinine level > 1.5 mg/dl

5. 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

6. Any physiologic or mechanical problems preventing dietary adherence

7. Pregnant or lactating

8. Participating in another dietary program or use of weight-loss medications

9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

10. Use of psychotropic or anoretic medication during the month immediately prior to study onset

11. Night or rotating shift work

12. Jet lag during the 2 week period immediately prior to study onset

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Daniela Jakubowicz

Prof. Daniela Jakubowicz MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Jakubowicz, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Unit E. Wolfson Medical Center Tel Aviv University

Mona Boaz, PhD

Role: STUDY_DIRECTOR

E. Wolfson Medical Center Tel Aviv University

Julio Wainstein, MD

Role: STUDY_CHAIR

E. Wolfson Medical Center

Locations

Daniela Jakubowicz

Holon, Tel Aviv, Israel

Countries

Israel

Other Identifiers

0048-12-WOMC

Identifier Type: -

Identifier Source: org_study_id