Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

This study has been completed.

Sponsor:

Information provided by:

GWT-TUD GmbH

ClinicalTrials.gov Identifier:

NCT00629213

First received: February 22, 2008

Last updated: March 5, 2008

Last verified: March 2008

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 NLM:

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Acarbose

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

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
Active Comparator: 1	Drug: acarbose
Placebo Comparator: 2	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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany
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.

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

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.


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

Keywords provided by GWT-TUD GmbH:


prevention, type 2 diabetes, metabolic syndrome, acarbose treatment

Additional relevant MeSH terms:


Metabolic Syndrome X Syndrome Disease Glucose Metabolism Disorders	Hyperinsulinism Insulin Resistance Metabolic Diseases Pathologic Processes

ClinicalTrials.gov processed this record on February 27, 2015

To Top