Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome (M-PCOS)
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ClinicalTrials.gov Identifier: NCT01569425 |
Recruitment Status
: Unknown
Verified April 2015 by Daniela Jakubowicz, Tel Aviv University.
Recruitment status was: Active, not recruiting
First Posted
: April 3, 2012
Last Update Posted
: April 8, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperandrogenism Insulin Resistance | Other: Dietary intervention | Not Applicable |
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 : | 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Lifestyle counseling
Lifestyle counseling, with high calorie breakfast
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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
|
- hyperandrogenism [ Time Frame: 90 days ]Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution
- 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

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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Jet lag during the 2 week period immediately prior to study onset

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569425
Israel | |
Daniela Jakubowicz | |
Holon, Tel Aviv, Israel, 58100 |
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 |
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 Key Record Dates |
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 |