Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00629213
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 7, 2008
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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).

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: acarbose Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: acarbose
Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  1. Incidence of newly diagnosed type 2 diabetes

Secondary Outcome Measures :
  1. newly diagnosed hypertension

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629213

Dresden, Saxony, Germany, 01187
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00629213     History of Changes
Other Study ID Numbers: Canadian: ACRI02; Bay g 5421
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs