Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status.

Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (IFG).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Treatments: Acarbose

Criteria

Inclusion Criteria:

• High risk population

• Age 40 to 70 yrs.

• BMI > 25 and < 40; FPG >5.5 mmol/l and < 7.8 mmol/l; IGT in OGGT

Exclusion Criteria:

• Known type 2 diabetes

• Drug intake affecting glucose tolerance

• Any cardiovascular events within the last 6 months