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NCT00629213 Clinical Trial

Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00629213
Other study ID # Canadian: ACRI02; Bay g 5421
Secondary ID
Status Completed
Phase Phase 3
First received February 22, 2008
Last updated March 5, 2008

Study information
Verified date March 2008
Source GWT-TUD GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Governmental Authority of Saxony, Regierungspraesidium Dresden
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 1429
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• acarbose

• placebo

Locations
Country Name City State
Germany GWT-TUD GmbH Dresden Saxony

Sponsors (1)
Lead Sponsor Collaborator
GWT-TUD GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of newly diagnosed type 2 diabetes
Secondary newly diagnosed hypertension
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