Type of study, patients, and inclusion criteria
- ß-cell function was measured using hyperglycaemic clamps and oral glucose tolerance tests (OGTTs).
- Main inclusion criteria included age 21-65 years, BMI 30-40 kg/m2, fasting glucose >90 mg/dl, 2-hour OGTT glucose ≥140 mg/dl, HbA1c ≤7.0%, diabetes duration <1 year and treatment naive for diabetes medication.
- Participants were randomised 1:1 to gastric banding or metformin.
- Total number of enrolees: 70.
- Duration of follow-up: 24 months.
Primary outcome measure
- Two co-primary outcomes were used to measure ß-cell responses:
- Steady-state C-peptide (SSCP)
- Acute C-peptide response at maximal glycaemia (ACPRmax).
Secondary outcome measures
- Glucose measure:
- OGTT fasting and 2-hour glucose
- OGTT glucose tolerance status
- Additional ß-cell measures.
- Blood pressure, lipids, liver enzymes.
- Adverse events.