Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial
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ClinicalTrials.gov Identifier: NCT00629213 |
Recruitment Status
:
Completed
First Posted
: March 5, 2008
Last Update Posted
: March 7, 2008
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome | Drug: acarbose Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 1429 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1 | Drug: acarbose |
Placebo Comparator: 2 | Drug: placebo |
- Incidence of newly diagnosed type 2 diabetes
- newly diagnosed hypertension

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629213
Germany | |
GWT-TUD GmbH | |
Dresden, Saxony, Germany, 01187 |
Publications:
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 |
First Posted: | March 5, 2008 Key Record Dates |
Last Update Posted: | March 7, 2008 |
Last Verified: | March 2008 |
Keywords provided by GWT-TUD GmbH:
prevention, type 2 diabetes, metabolic syndrome, acarbose treatment |
Additional relevant MeSH terms:
Syndrome Metabolic Syndrome X Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |
Metabolic Diseases Acarbose Glycoside Hydrolase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |