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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hyperandrogenism; Insulin Resistance	Other: Dietary intervention	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
Study Start Date :	March 2012
Actual Primary Completion Date :	June 2012
Estimated Study Completion Date :	June 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Lifestyle counseling; Lifestyle counseling, with high calorie breakfast	Other: Dietary intervention; High Calorie breakfast and high calorie dinner
Active Comparator: Life Counseling; Diet with high calorie dinner	Other: Dietary intervention; High Calorie breakfast and high calorie dinner

Outcome Measures

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Primary Outcome Measures :

1. hyperandrogenism [ Time Frame: 90 days ]
   Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution

Secondary Outcome Measures :

1. glucose metabolism [ Time Frame: 90 days ]
   Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Daniela Jakubowicz
Holon, Tel Aviv, Israel, 58100

Sponsors and Collaborators

Tel Aviv University

Investigators

Principal Investigator:	Daniela Jakubowicz, MD	Diabetes Unit E. Wolfson Medical Center Tel Aviv University
Study Director:	Mona Boaz, PhD	E. Wolfson Medical Center Tel Aviv University
Study Chair:	Julio Wainstein, MD	E. Wolfson Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Daniela Jakubowicz, Prof. Daniela Jakubowicz MD, Tel Aviv University
ClinicalTrials.gov Identifier:	NCT01569425 History of Changes
Other Study ID Numbers:	0048-12-WOMC
First Posted:	April 3, 2012
Last Update Posted:	April 8, 2015
Last Verified:	April 2015

Keywords provided by Daniela Jakubowicz, Tel Aviv University:

PCOS

Additional relevant MeSH terms:

Polycystic Ovary Syndrome; Insulin Resistance; Hyperandrogenism; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; 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