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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629213

Enrollment

1429

Registered

2008-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2008-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

prevention,, type 2 diabetes,, metabolic syndrome,, acarbose treatment

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).

Interventions

DRUGplacebo

DRUGacarbose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of newly diagnosed type 2 diabetes	—

Secondary

Measure	Time frame
newly diagnosed hypertension	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026