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Improving Beta Cell Function in Mexican American Women With Prediabetes

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ClinicalTrials.gov Identifier: NCT02488057
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
David Bradley MD, Ohio State University

Brief Summary:

This study will examine the benefits of weight loss alone or in combination with a GLP1 receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA) women with prediabetes. The Investigators have chosen to focus on MA women because MA women are at very high risk for progression to diabetes and have not traditionally been involved in weight management studies since they are thought to be difficult to recruit and retain in such programs. However, investigators have had particular success in working with young MA women using specifically developed ethnic and gender conscious programs. Because weight loss does not prevent all progression to diabetes, some participants will receive the diabetes medication, liraglutide, which has been shown to stabilize beta cell function. The study will also interrogate for polymorphisms of known T2DM genes to correlate with beta cell response to weight loss and liraglutide treatment. Additionally, this investigation targets serious health disparities in metabolic disease in a highly vulnerable, rapidly growing population, testing novel gender and culturally focused intervention strategies and identifying genetic biomarkers of response to a pharmacologic intervention that targets the pancreatic ßcell.

These results will help to a) understand mechanisms of disease, b) personalize treatment through identification of a high risk group that may be amenable to specific therapy, and c) ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic and costly disease, in Mexican Americans.


Condition or disease Intervention/treatment Phase
Pre-Diabetes Drug: Liraglutide Behavioral: Weight loss Phase 4

Detailed Description:
Investigators will test the hypothesis that liraglutide, because of its actions on the β-cell, will amplify the effects of lifestyle management to improve β-cell function. Investigators will recruit MA ages 18-40, since above this age the incidence of T2DM in obese MA women in our experience approaches 50%. The primary endpoint will be β-cell function (AIRg) in response to lifestyle change with and without GLP-1 agonist at 3 months. Secondary endpoints will be reversal of metabolic syndrome and changes in plasma biomarkers. By the end of 3 months, the prediabetic subject will be in the best possible metabolic control, and investigators would predict that the liraglutide group would reveal better β-cell function. Thus, data from this time point will be used for pharmacogenetic studies. The program will be continued for 3 more months for transition to regular healthy meals with the goal of weight maintenance. During this second 3 months, subjects will be off liraglutide to determine the sustainability of the improved β-cell function. In the absence of weight re-gain, investigators predict that the intensive weight loss alone group would maintain improved β-cell function, but the intensive weight loss+liraglutide group would display even better function. These results will provide useful information about improving β-cell function in the management of young women with pre-diabetes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Beta Cell Function in Mexican American Women With Prediabetes
Study Start Date : May 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Diet-induced weight loss
Investigators will randomize subjects to lifestyle change or lifestyle change plus GLP-1 receptor agonist. Lifestyle change will be developed around a meal replacement strategy. The intervention will be weight loss using Slim-Fast®. Participants will be provided Slim-Fast® meal replacement shakes to utilize for two meals daily plus one to two 100 calorie snacks, similar to the Look AHEAD protocol. The subjects will receive specific menus and training on food composition to prepare one healthy 500 calorie meal daily, for a net hypocaloric diet.
Behavioral: Weight loss
Active comparator. See arm descriptions.

Active Comparator: Weight loss plus liraglutide
Patients will be randomized to lifestyle change and the GLP-1 agonist, liraglutide. Subjects in this group will be administered 0.6mg liraglutide, sq injection daily for 1 week, increased to 1.2 mg for 1 week, and then 3.0 mg for the next 10 weeks of the acute phase. This gradual escalation of the dose is designed to minimize gastrointestinal side effects. Empty syringes will be monitored for compliance.
Drug: Liraglutide
Active comparator. See arm descriptions.
Other Name: Saxenda

Behavioral: Weight loss
Active comparator. See arm descriptions.




Primary Outcome Measures :
  1. Beta Cell Function [ Time Frame: 3 months ]
    disposition index: x10^-5min-1


Secondary Outcome Measures :
  1. Waist Circumference [ Time Frame: 3 months ]
    inches

  2. Fasting Glucose [ Time Frame: 3 months ]
    mg/dL

  3. Triglycerides [ Time Frame: 3 months ]
    mg/dL

  4. HDL cholesterol [ Time Frame: 3 months ]
    mg/dL

  5. Blood Pressure [ Time Frame: 3 months ]
    mmHg

  6. Heart Sensitive C-reactive protein [ Time Frame: 3 months ]
    hsCRP, mg/L

  7. Presence of genetic polymorphisms [ Time Frame: 3 months ]
    yes or no



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.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mexican-american
  • Female
  • BMI 30-42
  • willingness to complete protocol
  • pre-diabetic
  • English or Spanish literate

Exclusion Criteria:

  • pregnant
  • 30 min or more of moderate to vigorous activity more than 3 times per week
  • cardiovascular disease
  • physical limitations that might be aggravated by moderate physical activity
  • planning to move in next 12-24 months
  • diabetic

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): NCT02488057


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
L.A. Biomedical Research Institute
Torrance, California, United States, 90502
United States, Texas
Magnolia Multiservice Center
Houston, Texas, United States, 77011
Denver Harbor Multi-service Center
Houston, Texas, United States, 77020
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: David Bradley, MD Ohio State University
Publications:

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Responsible Party: David Bradley MD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02488057    
Other Study ID Numbers: 2014H0478
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication, presentation
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists