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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 : April 18, 2019
Sponsor:
Collaborators:
Nutrisystem, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Cornell University

Tracking Information
First Submitted Date  ICMJE February 1, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date April 18, 2019
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Ovulation during a weight loss intervention in women with PCOS [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT01785719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
  • Endometrial development during a weight loss intervention in women with PCOS [ Time Frame: 16 weeks ]
  • Changes in metabolism and body composition during a weight loss intervention in women with PCOS [ Time Frame: Baseline and 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss
Official Title  ICMJE Ultrasound Characterization of Ovarian Follicle Dynamics During Weight Loss
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 obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).
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 obese women with regular menstrual cycles versus obese 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 obese (i.e. body mass index >30 kg/m*m) women with regular menstrual cycles and up to 50 obese women with irregular menstrual cycles and/or PCOS. Exclusion criteria will include ages <18 or >35 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
The researchers plan to recruit two cohorts of obese 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
Condition  ICMJE
  • Weight Loss
  • Anovulation
  • Amenorrhea
  • Infertility
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Commercial Weight Loss Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2013)
30
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI ≥ 30.0 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
  • Vegan or gluten free
  • Soy or peanut allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marla Lujan, PhD 607-255-3153 marla.lujan@cornell.edu
Contact: Laura Galley, BS 607-255-3243 leg96@cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01785719
Other Study ID Numbers  ICMJE OSP 69298
R56HD089962 ( U.S. NIH Grant/Contract )
R01HD093748-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cornell University
Study Sponsor  ICMJE Cornell University
Collaborators  ICMJE
  • Nutrisystem, Inc.
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Marla Lujan, PhD Cornell University
PRS Account Cornell University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP