NCT00629213

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,429

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

March 7, 2008

Status Verified

March 1, 2008

First QC Date

February 22, 2008

Last Update Submit

March 5, 2008

Conditions

Metabolic Syndrome

Keywords

prevention,type 2 diabetes,metabolic syndrome,acarbose treatment

Outcome Measures

Primary Outcomes (1)

  • Incidence of newly diagnosed type 2 diabetes

Secondary Outcomes (1)

  • newly diagnosed hypertension

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: acarbose

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

acarboseDRUG
1
placeboDRUG
2

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known type 2 diabetes
  • Drug intake affecting glucose tolerance
  • Any cardiovascular events within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GWT-TUD GmbH

Dresden, Saxony, 01187, Germany

Location

Related Publications (2)

  • 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. doi: 10.1016/S0140-6736(02)08905-5.

    PMID: 12086760BACKGROUND

  • 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.

    PMID: 19156626DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 5, 2008

Last Updated

March 7, 2008

Record last verified: 2008-03

Locations

DE(1)