Trial record 1 of 1 for:    NCT01763346
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Beta Cell Restoration Through Fat Mitigation (BetaFat)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01763346
First received: January 4, 2013
Last updated: May 23, 2013
Last verified: May 2013

January 4, 2013
May 23, 2013
January 2013
March 2017   (final data collection date for primary outcome measure)
  • Steady state beta cell compensation [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ClinicalTrials.gov Archive Site
  • Changes in body fat [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]
    total and regional fat assessed by DEXA and MRI
  • Acute beta cell compensation [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    fasting and OGTT glucose levels, HbA1C
  • Blood and urine biomarkers [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Prediabetes
  • Type 2 Diabetes
  • Obesity
  • Drug: Metformin
    metformin 1000 mg bid
  • Device: gastric banding
    LAP-BAND
  • 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 Mar;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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
June 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Fasting plasma glucose >90 mg/dl
  2. 2-hour glucose ≥140 mg/dl on 75 gm OGTT
  3. HbA1C ≤7.0%.
  4. Age 20-65 years
  5. Body mass index (BMI) 30-40 kg/m2 despite at least one attempt at weight loss
  6. For participants with diabetes, known duration <1 year
  7. No history of use of antidiabetic medications

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
Both
20 Years to 65 Years
No
Contact: Enrique Trigo trigo@usc.edu
United States
 
NCT01763346
BETAFAT, U01DK094430, IIT - 000395
Yes
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
May 2013

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