Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

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

Sponsors

Lead Sponsor: GWT-TUD GmbH

Source GWT-TUD GmbH
Brief 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).

Overall Status Completed
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of newly diagnosed type 2 diabetes
Secondary Outcome
Measure Time Frame
newly diagnosed hypertension
Enrollment 1429
Condition
Intervention

Intervention Type: Drug

Intervention Name: acarbose

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: placebo

Arm Group Label: 2

Eligibility

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

Gender: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Location
Facility: GWT-TUD GmbH
Location Countries

Germany

Verification Date

March 2008

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

Label: 2

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov