Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial - Full Text View

Sponsored by:	GWT-TUD GmbH
Information provided by:	GWT-TUD GmbH
ClinicalTrials.gov Identifier:	NCT00629213

Purpose

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Acarbose

U.S. FDA Resources

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

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
1: Active Comparator	Drug: acarbose
2: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629213

Locations

Germany, Saxony
GWT-TUD GmbH
Dresden, Saxony, Germany, 01187

Sponsors and Collaborators

GWT-TUD GmbH

More Information

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.

Study ID Numbers:	Canadian: ACRI02; Bay g 5421
Study First Received:	February 22, 2008
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00629213
Health Authority:	Germany: Governmental Authority of Saxony, Regierungspraesidium Dresden

Keywords provided by GWT-TUD GmbH:

prevention,
type 2 diabetes,
metabolic syndrome,
acarbose treatment

Study placed in the following topic categories:

Acarbose
Glucose Intolerance
Diabetes Mellitus, Type 2
Diabetes Mellitus

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Syndrome
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009