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Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss

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ClinicalTrials.gov Identifier: NCT01785719
Recruitment Status : Recruiting
First Posted : February 7, 2013
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
Nutrisystem, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cornell University

Brief Summary:
The objective of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in overweight women with regular menstrual cycles versus overweight women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).

Condition or disease Intervention/treatment Phase
Weight Loss Anovulation Amenorrhea Infertility Behavioral: Commercial Weight Loss Program Not Applicable

Detailed Description:

Polycystic ovary syndrome (PCOS) is a complex endocrine condition that impacts one in ten women of reproductive age worldwide. It is characterized by a collection of signs and symptoms, including: (1) oligo- or anovulation, (2) hyperandrogenism, and (3) polycystic ovarian morphology. Because obesity worsens the reproductive and metabolic features of the condition, lifestyle intervention aimed at weight loss is recommended as the first-line therapy in overweight / obese patients. Many studies have shown that modest weight loss (5-10%) can improve symptomology in women with PCOS. Yet, the mechanism whereby weight loss might stimulate ovulation or restore menstrual cyclicity remains unclear.

Hence, the goal of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in overweight women with regular menstrual cycles versus overweight women with irregular menstrual cycles and/or PCOS. The researchers believe that a hypocaloric and low-glycemic index eating pattern, based on the nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes Association, will reduce endocrine and metabolic disturbances and consequently improve ovulatory and menstrual cyclicity in PCOS.

To accomplish this objective, the researchers plan to recruit up to 50 overweight (i.e. body mass index >25.0 kg/m*m) women with regular menstrual cycles and up to 50 overweight women with irregular menstrual cycles and/or PCOS. Exclusion criteria will include ages <18 or >38 y and the use of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment. This study entails one month of data collection during a baseline interval (Month 1) and six months of data collection during a commercial weight loss program (Nutrisystem® D; Month 2 thru Month 7).

Participants will be evaluated every other day (in Months 1 and 7) or twice per week (in Months 2 thru 6) by transvaginal ultrasonography and venipuncture. Ultrasound images of the ovaries will be assessed for the total number and diameter of individual follicles. Serum samples will be assessed for follicle-stimulating hormone, luteinizing hormone, estradiol, and progesterone. Participants will also be evaluated at up to four time points using multiple metabolic and behavioral tests. Time points of interest will include: (1) Month 1 (i.e. pre-intervention), (2) after 5% weight loss, (3) after 10% weight loss, and (4) Month 7 (i.e. post-intervention). Assessments and endpoints of interest will include: (1) fasting blood tests (to detect serum androgens and markers of metabolic syndrome); (2) an oral glucose tolerance test (to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120-minutes post-glucose ingestion); (3) a physical examination (to measure height, weight, waist and hips circumference, blood pressure, heart rate, and hirsutism score); (4) a dual x-ray absorptiometry scan (to quantify total and regional fat and lean mass); and (5) a quality of life questionnaire (to evaluate health-related quality of life).

To evaluate further changes in ovarian morphology, reproductive hormones, metabolic status, and body composition after the intervention, participants will be invited to return to the research unit six months after the study ends. The aforementioned procedures (transvaginal ultrasound scan; fasting blood tests; oral glucose tolerance test; physical examination; dual x-ray absorptiometry scan; and quality of life questionnaire) will be repeated.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The researchers plan to recruit two cohorts of overweight women to the study: (1) those with irregular menstrual cycles and/or PCOS and (2) those with regular menstrual cycles. Both of the cohorts will receive the same intervention.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ultrasound Characterization of Ovarian Follicle Dynamics During Weight Loss
Study Start Date : January 2013
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Overweight Women
Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.
Behavioral: Commercial Weight Loss Program
Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.




Primary Outcome Measures :
  1. Change from Baseline Ovulatory Function [ Time Frame: Up to 7 months ]
    Ovulation will be identified by the disappearance of a dominant follicle and subsequent appearance of a corpus luteum on ultrasonography. The event will be confirmed by a corresponding increase in serum progesterone.


Secondary Outcome Measures :
  1. Change from Baseline Menstrual Function [ Time Frame: through study completion, an average of 13 months ]
    Menses will be confirmed by participant self-report of uterine bleeding.

  2. Change from Baseline Ovarian Morphology [ Time Frame: through study completion, an average of 13 months ]
    Information about the associated procedures and endpoints are provided elsewhere.

  3. Change from Baseline Reproductive Hormones [ Time Frame: through study completion, an average of 13 months ]
    Information about the associated procedures and endpoints are provided elsewhere.

  4. Change from Baseline Metabolic Status [ Time Frame: through study completion, an average of 13 months ]
    Information about the associated procedures and endpoints are provided elsewhere.

  5. Change from Baseline Body Composition [ Time Frame: through study completion, an average of 13 months ]
    Information about the associated procedures and endpoints are provided elsewhere.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 25.0 kg/m*m.
  • Self-reported history of regular menstrual cycles, irregular menstrual cycles, or PCOS.
  • Absence of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment.

Exclusion Criteria:

  • Pregnant, breastfeeding, or lactating
  • Lack of one or both ovaries and/or uterus
  • Previous diagnosis of bleeding disorder(s) or current use of blood thinners/anticoagulants
  • Vegetarian, vegan, or gluten free

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): NCT01785719


Contacts
Contact: Marla Lujan, PhD 607-255-3153 marla.lujan@cornell.edu
Contact: Brittany Jarrett, PhD, RD 607-255-0889 BYJ4@cornell.edu

Locations
United States, New York
Cornell University - Human Metabolic Research Unit Recruiting
Ithaca, New York, United States, 14853
Contact: Erica Bender, CNM, NP    607-255-9417    eb572@cornell.edu   
Principal Investigator: Marla E. Lujan, PhD         
Sponsors and Collaborators
Cornell University
Nutrisystem, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Marla Lujan, PhD Cornell University
  Study Documents (Full-Text)

Documents provided by Cornell University:
Statistical Analysis Plan  [PDF] May 4, 2018


Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01785719     History of Changes
Other Study ID Numbers: OSP 69298
R56HD089962 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cornell University:
Weight Loss
Polycystic Ovary Syndrome (PCOS)
Ovarian Follicle Development
Metabolism

Additional relevant MeSH terms:
Amenorrhea
Body Weight
Weight Loss
Infertility
Anovulation
Signs and Symptoms
Body Weight Changes
Genital Diseases, Male
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases