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

NCT01569425 | Unknown DMC

• 1 other identifier: 0048-12-WOMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperandrogenism; Insulin Resistance

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

• hyperandrogenism

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

  90 days

Secondary Outcomes (1)

• glucose metabolism

  90 days

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Lifestyle counseling, with high calorie breakfast

Other: Dietary intervention

Life Counseling

ACTIVE COMPARATOR

Diet with high calorie dinner

Other: Dietary intervention

Interventions

Dietary intervention OTHER

High Calorie breakfast and high calorie dinner

Life Counseling; Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects ≥18 and ≤45 years of age
• Lean women with PCOS (BMI: ≤ 25 kg/m2)
• Signed informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Daniela Jakubowicz

Holon, Tel Aviv, 58100, Israel

Location

MeSH Terms

Conditions

Hyperandrogenism; Insulin Resistance

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Daniela Jakubowicz, MD

  Diabetes Unit E. Wolfson Medical Center Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Mona Boaz, PhD

  E. Wolfson Medical Center Tel Aviv University

  STUDY DIRECTOR

• Julio Wainstein, MD

  E. Wolfson Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Daniela Jakubowicz MD

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

IL (1)