Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

GWT-TUD GmbH1,429 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

1,429

Conditions

Metabolic Syndrome

Interventions

acarboseDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

GWT-TUD GmbH

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Incidence of newly diagnosed type 2 diabetes

Secondary Outcomes

newly diagnosed hypertension

Data from ClinicalTrials.gov

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