Ultrasound Characterization of Ovarian Morphology During Weight Loss in Women With Polycystic Ovary Syndrome (PCOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Cornell University
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01785719
First received: February 1, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to investigate the effects of weight loss on ovarian morphology, metabolism, and body composition in overweight and obese women with polycystic ovary syndrome (PCOS).


Condition Intervention
Weight Loss
Anovulation
Amenorrhea
Infertility
Behavioral: Commercial diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Ultrasound Characterization of Follicle Dynamics During Weight Loss

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Ovulation during a weight loss intervention in women with PCOS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endometrial development during a weight loss intervention in women with PCOS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Changes in metabolism and body composition during a weight loss intervention in women with PCOS [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Changes in ovarian morphology, metabolism, and body composition in the six months after a weight loss intervention in women with PCOS [ Time Frame: At six months after the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Commercial diet
Participants will be enrolled in 12 weeks of the Nutrisystem® D weight loss program; a portion-controlled, low calorie and low glycemic index meal delivery system that provides 1250-1500 calories per day. Nutrisystem® D has been proven to help overweight individuals achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, typical weight loss is 1-2 lbs per week, for an average loss of 8% body weight by the end of 3 months. Nutrisystem® D offers a balanced meal plan consistent with the nutritional recommendations of the USDA Dietary Guidelines and American Diabetes Association; individuals can still consume all of their required micro- and macronutrients, but with fewer calories.
Behavioral: Commercial diet
Participants will be enrolled in 12 weeks of the Nutrisystem® D weight loss program; a portion-controlled, low calorie and low glycemic index meal delivery system that provides 1250-1500 calories per day. Nutrisystem® D has been proven to help overweight individuals achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, typical weight loss is 1-2 lbs per week, for an average loss of 8% body weight by the end of 3 months. Nutrisystem® D offers a balanced meal plan consistent with the nutritional recommendations of the USDA Dietary Guidelines and American Diabetes Association; individuals can still consume all of their required micro- and macronutrients, but with fewer calories.

Detailed Description:

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic ovarian morphology. Since the majority of patients also present with obesity, insulin resistance, dyslipidemia, and/or other risk factors for metabolic syndrome, there is a definite need for the development of therapeutic strategies to help these women lose weight and improve their metabolic and reproductive function.

At present, there is evidence to suggest that the loss of as little as 5-10% of body weight through prescribed diet and lifestyle interventions can improve symptomology in women with PCOS. However, the mechanism whereby weight loss specifically stimulates ovulation and restores menstrual cyclicity is unclear. Hence, the goal of this study is to explore the effects of weight loss on ovarian morphology, metabolism, and body composition in overweight and obese women with PCOS. The researchers believe that a dietary intervention based on the nutritional recommendations of the USDA Dietary Guidelines for Americans, and supported by the Obesity Society and American Diabetes Association, will reduce the degree of metabolic disturbances and consequently restore healthy ovarian follicle development in women with PCOS.

To accomplish these objectives, 30 overweight (BMI 25-29.9 kg/m^2) or obese (BMI ≥ 30 kg/m^2) women with PCOS will be evaluated every-other-day by 3D transvaginal ultrasonography during a 4-week baseline interval and 12-week commercial weight loss program (Nutrisystem® D). Participants will range in age from 18 - 38 and will not have used hormonal contraception, fertility therapies, or insulin sensitizers in the three months prior to enrollment. Ultrasound scans of the ovaries will be assessed for the total number and size of follicles using both two- and three-dimensional imaging techniques. Participants will have blood samples collected every visit to track changes in LH, FSH, estrogens, and progesterone during the scanning interval. The following metabolic parameters will be assessed at Week 2 of the baseline interval and Weeks 6 and 12 of the commercial weight loss program: (1) 75-gram oral glucose tolerance test to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120 minutes post-glucose ingestion; (2) dual X-ray absorptiometry (DXA) scan to quantify body fat and lean muscle distribution; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate, and (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index) and serum markers of metabolic syndrome (i.e., lipids and hemoglobin A1C).

Further, to evaluate the effects of ovarian morphology, metabolism, and body composition on sustained weight loss and/or weight maintenance in overweight and obese women with PCOS, participants will be invited to return six months after their intervention is complete. The aforementioned procedures, including transvaginal ultrasound, 75-gram oral glucose tolerance test, DXA, vitals and anthropometry assessment, and fasting tests will be repeated.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 25.0 kg/m2
  • Self-reported history of infrequent or absent menstrual cycles and/or PCOS
  • Did not take hormonal contraception, fertility therapies, or insulin sensitizers 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785719

Contacts
Contact: Marla E. Lujan, PhD 607-255-3153 MEL245@cornell.edu
Contact: Brittany Y. Jarrett, BSc 607-255-0889 BYJ4@cornell.edu

Locations
United States, New York
Human Metabolic Research Unit, Cornell University Recruiting
Ithaca, New York, United States, 14853
Contact: Erica Bender, MSN, CNM    607-255-9417    eb572@cornell.edu   
Principal Investigator: Marla E. Lujan, PhD         
Sponsors and Collaborators
Cornell University
Nutrisystem, Inc.
Investigators
Principal Investigator: Marla E. Lujan, PhD Cornell University
  More Information

No publications provided

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01785719     History of Changes
Other Study ID Numbers: OSP 69298
Study First Received: February 1, 2013
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 14, 2014