N/A
N=88
Beta Cell Restoration Through Fat Mitigation
Prediabetes · Type 2 Diabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01763346 ↗Enrolled (actual)
88
Serious AEs
7.8%
Results posted
Oct 2019
Primary outcome: Primary: Steady State Beta Cell Compensation — 3.01; 3.19 (nmol/L) adjusted for M/I — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metformin (Drug); gastric banding (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady State Beta Cell Compensation |
3.01; 3.19 | 0.05 |
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.
Eligibility Criteria
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 5.5 mmol/l)
- Anemia (hemoglobin 3 times upper limit of normal in local clinical lab
- Excessive alcohol intake
- Suboptimally treated thyroid disease
- 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
Data sourced from ClinicalTrials.gov (NCT01763346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.