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Clinical Trials/NCT00629213
NCT00629213
Completed
Phase 3

Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The STOP-NIDDM Trial

GWT-TUD GmbH1 site in 1 country1,429 target enrollmentMarch 5, 2008
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ConditionsMetabolic Syndrome
Interventionsacarboseplacebo
Drugsacarboseplacebo

Overview

Phase
Phase 3
Intervention
acarbose
Conditions
Metabolic Syndrome
Sponsor
GWT-TUD GmbH
Enrollment
1429
Locations
1
Primary Endpoint
Incidence of newly diagnosed type 2 diabetes
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 5, 2008
End Date
TBD
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

1

Intervention: acarbose

2

Intervention: placebo

Outcomes

Primary Outcomes

Incidence of newly diagnosed type 2 diabetes

Secondary Outcomes

  • newly diagnosed hypertension

Study Sites (1)

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