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Beta Cell Restoration Through Fat Mitigation (BetaFat)

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.
 
ClinicalTrials.gov Identifier: NCT01763346
Recruitment Status : Completed
First Posted : January 8, 2013
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas Buchanan, University of Southern California

Study Description
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Brief Summary:
Weight loss achieved through gastric banding will be superior to treatment with metformin in preserving or restoring pancreatic beta cell function in people with prediabetes or mild type 2 diabetes.

Condition or disease Intervention/treatment Phase
Prediabetes Type 2 Diabetes Obesity Drug: Metformin Device: gastric banding Not Applicable

Detailed Description:
BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The primary outcome will be change in β-cell compensation for insulin resistance, which the investigators will compare between groups. Secondary analyses will include other potential markers of β-cell health and potential mediators of treatment-specific effects. The main focus will be on mediators related to obesity. Clinically, the project will serve as a test of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell disease. Biologically, the results will provide crucial information on potential mediators of β-cell failure and its arrest or reversal in the context of obesity. Those mediators will guide the development of more effective treatment and monitoring for the β-cell disease that causes type 2 diabetes.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Beta Cell Restoration Through Fat Mitigation
Study Start Date : June 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: metformin
subjects receiving metformin
 Drug: Metformin
metformin 1000 mg bid
Experimental: gastric banding
subjects receiving LAP-BAND
 Device: gastric banding
LAP-BAND


Outcome Measures
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Primary Outcome Measures :
  1. Steady State Beta Cell Compensation [ Time Frame: 24 months ]
    mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity


Other Outcome Measures:
  1. Glycemia [ Time Frame: 24 months ]
    fasting and 2-hour OGTT glucose levels

  2. Glycemia [ Time Frame: 24 months ]
    HbA1C


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prior completion of at least two months in a diet, exercise and lifestyle intervention program within the past two years
  2. Fasting plasma glucose >90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1C ≤7.0%. There is no lower limit for the A1C and no upper limit for the OGTT 2-hour glucose based on prior studies that allow us to identify people with falling β-cell function
  3. Age 22-65 years
  4. Body mass index (BMI) 30-40 kg/m2
  5. For participants with diabetes, known duration <1 year
  6. No history of use of antidiabetic medications except during pregnancy

Exclusion Criteria:

  1. Contraindications to LapBand(see Appendix 1)
  2. Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
  3. Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
  4. An underlying disease known to have important effects on glucose metabolism
  5. Active infections
  6. Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
  7. Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
  8. Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
  9. Serum AST >3 times upper limit of normal in local clinical lab
  10. Excessive alcohol intake
  11. Suboptimally treated thyroid disease

  12. Conditions or behaviors likely to affect the conduct of the study

    1. unable or unwilling to give informed consent
    2. unable to adequately communicate with clinic staff
    3. another household member is a participant or staff member
    4. current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes
    5. likely to move away from participating clinic in next 2 years
    6. current (or anticipated) pregnancy and lactation.
    7. major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of the study
    8. weight loss >5% in past three months for any reason except postpartum weight loss.
  13. additional conditions may serve as criteria for exclusion at the discretion of the local site
Contacts and Locations
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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): NCT01763346


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 91011
Sponsors and Collaborators
University of Southern California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Thomas A Buchanan, MD University of Southern California
  Study Documents (Full-Text)

Documents provided by Thomas Buchanan, University of Southern California:
Study Protocol and Statistical Analysis Plan  [PDF] August 28, 2016
Informed Consent Form  [PDF] April 5, 2018

More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Buchanan, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01763346    
Other Study ID Numbers: BETAFAT
U01DK094430 ( U.S. NIH Grant/Contract )
IIT - 000395 ( Other Grant/Funding Number: Allergan Corporation )
First Posted: January 8, 2013    Key Record Dates
Results First Posted: October 21, 2019
Last Update Posted: October 21, 2019
Last Verified: September 2019
Keywords provided by Thomas Buchanan, University of Southern California:
type 2 diabetes
prediabetes
obesity
gastric banding
metformin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs