Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

G

GWT-TUD GmbH

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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