- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569425
Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome (M-PCOS)
Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tel Aviv
-
Holon, Tel Aviv, Israel, 58100
- Daniela Jakubowicz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lifestyle counseling
Lifestyle counseling, with high calorie breakfast
|
High Calorie breakfast and high calorie dinner
|
ACTIVE_COMPARATOR: Life Counseling
Diet with high calorie dinner
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High Calorie breakfast and high calorie dinner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hyperandrogenism
Time Frame: 90 days
|
Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mona Boaz, PhD, E. Wolfson Medical Center Tel Aviv University
- Study Chair: Julio Wainstein, MD, E. Wolfson Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Endocrine System Diseases
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- 46, XX Disorders of Sex Development
- Disorders of Sex Development
- Urogenital Abnormalities
- Adrenogenital Syndrome
- Congenital Abnormalities
- Hyperinsulinism
- Polycystic Ovary Syndrome
- Hyperandrogenism
- Insulin Resistance
Other Study ID Numbers
- 0048-12-WOMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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