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Completed

NCT Number: NCT00629213

Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

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).

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Key information

Conditions

Metabolic Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GWT-TUD GmbH

Dresden, Saxony, 01187, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose

Drug

Placebo

Drug

Primary outcomes

  1. Incidence of newly diagnosed type 2 diabetes

Secondary outcomes

  1. newly diagnosed hypertension

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Registry information

Official study title

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

Important dates

First posted
Mar 5, 2008
Registry last updated
Mar 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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