Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

Phase 3

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: acarbose; Drug: placebo

• Registration Number: NCT00629213
• Lead Sponsor: GWT-TUD GmbH

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-22
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-05
• Last Update Submitted: 2008-03-05
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1429

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	acarbose	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of newly diagnosed type 2 diabetes

Secondary Outcome Measures

Name	Time	Method
newly diagnosed hypertension

Trial Locations

Locations (1)

GWT-TUD GmbH; 🇩🇪 Dresden, Saxony, Germany