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N/A N=88 Randomized Basic Science

Beta Cell Restoration Through Fat Mitigation

Prediabetes · Type 2 Diabetes · Obesity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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