Trial record 1 of 1 for:    NCT01763346
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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. Identifier: NCT01763346
Recruitment Status : Active, not recruiting
First Posted : January 8, 2013
Last Update Posted : August 29, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas Buchanan, University of Southern California

January 4, 2013
January 8, 2013
August 29, 2016
June 2013
July 2018   (Final data collection date for primary outcome measure)
  • Steady state beta cell compensation [ Time Frame: 0, 12, 24 months ]
    mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity
  • Maximum beta cell compensation [ Time Frame: 0, 12, 24 months ]
    area under plasma C-peptide curve 0-10 minutes after arginine bolus at hyperglycemia (~450 mg/dl), adjusted for insulin sensitivity
Same as current
Complete list of historical versions of study NCT01763346 on Archive Site
  • Changes in body fat [ Time Frame: 0, 12, 24 months ]
    total and regional fat assessed by DEXA and MRI
  • Acute beta cell compensation [ Time Frame: 0, 12, 24 months ]
    incremental area under insulin and, separately, C-peptide curves during first ten minutes after glucose injection, adjusted for insulin sensitivity
  • Steady state and maximal insulin responses [ Time Frame: 0, 12, 24 months ]
    Mean plasma insulin concentration at clamp steady state; area under plasma insulin curve 0-10 minutes after arginine bolus at hyperglycemia (~450 mg/dl)
  • Insulin responses to oral glucose [ Time Frame: 0, 12, 24 months ]
    30-min insulin and C-peptide responses and modeled parameters of beta cell function from 3-hour frequently sampled oral glucose tolerance tests
  • Insulin sensitivity [ Time Frame: 0, 12, 24 months ]
    ratio of clamp steady state glucose utilization to clamp steady state plasma insulin level; Matsuda index, HOMA-S
Same as current
  • glycemia [ Time Frame: 0, 12, 24 months ]
    fasting and OGTT glucose levels, HbA1C
  • Blood and urine biomarkers [ Time Frame: 0, 6, 12, 18, 24 months ]
    adipokines, fatty acids
Same as current
Beta Cell Restoration Through Fat Mitigation
Beta Cell Restoration Through Fat Mitigation
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Prediabetes
  • Type 2 Diabetes
  • Obesity
  • Drug: Metformin
    metformin 1000 mg bid
  • Device: gastric banding
  • Active Comparator: metformin
    subjects receiving metformin
    Intervention: Drug: Metformin
  • Experimental: gastric banding
    subjects receiving LAP-BAND
    Intervention: Device: gastric banding
RISE Consortium. Restoring Insulin Secretion (RISE): design of studies of β-cell preservation in prediabetes and early type 2 diabetes across the life span. Diabetes Care. 2014;37(3):780-8. doi: 10.2337/dc13-1879. Epub 2013 Nov 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
22 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
U01DK094430 ( U.S. NIH Grant/Contract )
IIT - 000395 ( Other Grant/Funding Number: Allergan Corporation )
Not Provided
Not Provided
Thomas Buchanan, University of Southern California
University of Southern California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Thomas A Buchanan, MD University of Southern California
University of Southern California
August 2016

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