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
  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:


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
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:
Additional 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
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:
Glucose Intolerance
Metabolic Syndrome X
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014