Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

This study has been completed.
Information provided by:
GWT-TUD GmbH Identifier:
First received: February 22, 2008
Last updated: March 5, 2008
Last verified: March 2008

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).

Condition Intervention Phase
Metabolic Syndrome
Drug: acarbose
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The STOP-NIDDM Trial

Resource links provided by NLM:

Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • Incidence of newly diagnosed type 2 diabetes

Secondary Outcome Measures:
  • newly diagnosed hypertension

Estimated Enrollment: 1429
Arms Assigned Interventions
Active Comparator: 1 Drug: acarbose
Placebo Comparator: 2 Drug: placebo


Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00629213

Dresden, Saxony, Germany, 01187
Sponsors and Collaborators
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00629213     History of Changes
Other Study ID Numbers: Canadian: ACRI02; Bay g 5421
Study First Received: February 22, 2008
Last Updated: March 5, 2008
Health Authority: Germany: Governmental Authority of Saxony, Regierungspraesidium Dresden

Keywords provided by GWT-TUD GmbH:
type 2 diabetes,
metabolic syndrome,
acarbose treatment

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 30, 2015