Beta Cell Restoration Through Fat Mitigation (BetaFat)
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ClinicalTrials.gov Identifier: NCT01763346 |
Recruitment Status :
Completed
First Posted : January 8, 2013
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prediabetes Type 2 Diabetes Obesity | Drug: Metformin Device: gastric banding | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: metformin
subjects receiving metformin
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Drug: Metformin
metformin 1000 mg bid |
Experimental: gastric banding
subjects receiving LAP-BAND
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Device: gastric banding
LAP-BAND |
- Steady State Beta Cell Compensation [ Time Frame: 24 months ]mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity
- Glycemia [ Time Frame: 24 months ]fasting and 2-hour OGTT glucose levels
- Glycemia [ Time Frame: 24 months ]HbA1C

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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 |
Inclusion Criteria:
- Prior completion of at least two months in a diet, exercise and lifestyle intervention program within the past two years
- 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
- Age 22-65 years
- Body mass index (BMI) 30-40 kg/m2
- For participants with diabetes, known duration <1 year
- No history of use of antidiabetic medications except during pregnancy
Exclusion Criteria:
- Contraindications to LapBand(see Appendix 1)
- Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
- 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
- An underlying disease known to have important effects on glucose metabolism
- Active infections
- 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)
- Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
- 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.
- Serum AST >3 times upper limit of normal in local clinical lab
- Excessive alcohol intake
- Suboptimally treated thyroid disease
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Conditions or behaviors likely to affect the conduct of the study
- unable or unwilling to give informed consent
- unable to adequately communicate with clinic staff
- another household member is a participant or staff member
- current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes
- likely to move away from participating clinic in next 2 years
- current (or anticipated) pregnancy and lactation.
- major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of the study
- weight loss >5% in past three months for any reason except postpartum weight loss.
- additional conditions may serve as criteria for exclusion at the discretion of the local site

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
United States, California | |
University of Southern California | |
Los Angeles, California, United States, 91011 |
Principal Investigator: | Thomas A Buchanan, MD | University of Southern California |
Documents provided by Thomas Buchanan, University of Southern California:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
type 2 diabetes prediabetes obesity gastric banding metformin |
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 |