Beta Cell Restoration Through Fat Mitigation

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metformin

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