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Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

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ClinicalTrials.gov Identifier: NCT00629213
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 7, 2008
Sponsor:
Information provided by:
GWT-TUD GmbH

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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

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


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

Secondary Outcome Measures :
  1. newly diagnosed hypertension

Eligibility Criteria
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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
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00629213


Locations
Germany
GWT-TUD GmbH
Dresden, Saxony, Germany, 01187
Sponsors and Collaborators
GWT-TUD GmbH
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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:
prevention,
type 2 diabetes,
metabolic syndrome,
acarbose treatment

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