- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629213
Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial
Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Saxony
-
Dresden, Saxony, Germany, 01187
- GWT-TUD GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
|
Active Comparator: 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Incidence of newly diagnosed type 2 diabetes
|
Secondary Outcome Measures
Outcome Measure |
---|
newly diagnosed hypertension
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trail Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002 Jun 15;359(9323):2072-7. doi: 10.1016/S0140-6736(02)08905-5.
- Hanefeld M, Karasik A, Koehler C, Westermeier T, Chiasson JL. Metabolic syndrome and its single traits as risk factors for diabetes in people with impaired glucose tolerance: the STOP-NIDDM trial. Diab Vasc Dis Res. 2009 Jan;6(1):32-7. doi: 10.3132/dvdr.2009.006.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Canadian: ACRI02; Bay g 5421
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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