Beta Cell Restoration Through Fat Mitigation | RxWiki

Beta Cell Restoration Through Fat Mitigation

Overview[ - collapse ][ - ]

Purpose	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	Prediabetes Type 2 Diabetes Obesity
Intervention	Drug: Metformin Device: gastric banding
Phase	N/A
Sponsor	University of Southern California
Responsible Party	University of Southern California
ClinicalTrials.gov Identifier	NCT01763346
First Received	January 4, 2013
Last Updated	May 23, 2013
Last verified	May 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 4, 2013
Last Updated Date	May 23, 2013
Start Date	January 2013
Estimated Primary Completion Date	June 2017
Current Primary Outcome Measures	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
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	Beta Cell Restoration Through Fat Mitigation
Official Title	Beta Cell Restoration Through Fat Mitigation
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.
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 Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Prediabetes Type 2 Diabetes Obesity
Intervention	Drug: Metformin metformin 1000 mg bid Device: gastric banding LAP-BAND
Study Arm (s)	Active Comparator: metformin subjects receiving metformin Experimental: gastric banding subjects receiving LAP-BAND

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	88
Estimated Completion Date	June 2017
Estimated Primary Completion Date	March 2017
Eligibility Criteria	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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Enrique Trigo trigo@usc.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01763346
Other Study ID Numbers	BETAFAT
Has Data Monitoring Committee	Yes
Information Provided By	University of Southern California
Study Sponsor	University of Southern California
Collaborators	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators	Principal Investigator: Thomas A Buchanan, MD University of Southern California
Verification Date	May 2013

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