Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

GWT-TUD

Status and phase: Completed; Phase 3

Conditions: Metabolic Syndrome

Treatments: Drug: acarbose; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00629213

Canadian: ACRI02 Bay g 5421;

Details and patient eligibility

About

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).

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,429 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: acarbose

2

Placebo Comparator group

Treatment:

Drug: placebo