We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Daniela Jakubowicz, Tel Aviv University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569425
First Posted: April 3, 2012
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University
  Purpose
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 Intervention
Hyperandrogenism Insulin Resistance Other: Dietary intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Daniela Jakubowicz, Tel Aviv University:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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

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 Submitted: March 30, 2012
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