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


N/A
18 Years
45 Years
Open (Enrolling)
Female
Hyperandrogenism, Insulin Resistance

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Trial Information

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


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.


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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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

hyperandrogenism

Outcome Description:

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

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

Daniela Jakubowicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Diabetes Unit E. Wolfson Medical Center Tel Aviv University

Authority:

Israel: Ethics Commission

Study ID:

0048-12-WOMC

NCT ID:

NCT01569425

Start Date:

March 2012

Completion Date:

June 2012

Related Keywords:

  • Hyperandrogenism
  • Insulin Resistance
  • PCOS
  • Insulin Resistance
  • Polycystic Ovary Syndrome
  • Hyperandrogenism

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