NCT00381186

Brief Summary

To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 1999

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

November 9, 2016

Status Verified

September 1, 2006

First QC Date

September 25, 2006

Last Update Submit

November 8, 2016

Conditions

Keywords

impaired glucose tolerancetype 2 diabetes

Outcome Measures

Primary Outcomes (2)

  • 2-hour glucose levels

  • insulin resistance

Secondary Outcomes (4)

  • adherence

  • type 2 diabetes

  • dietary intake change

  • exercise change

Interventions

Eligibility Criteria

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

You may qualify if:

  • caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8

You may not qualify if:

  • known type 2 diabetes, mean 2hr glucose \>12.5 mmol/l, mean fasting blood glucose \> 7.8 mmol/l, chronic illness that makes 5-year survival improbable, interferes with glucose tolerance or makes participation in a lifestyle intervention impossible, medication known to interfere with glucose tolerance, participation in a vigorous exercise and/or diet program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • den Boer AT, Herraets IJ, Stegen J, Roumen C, Corpeleijn E, Schaper NC, Feskens E, Blaak EE. Prevention of the metabolic syndrome in IGT subjects in a lifestyle intervention: results from the SLIM study. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1147-53. doi: 10.1016/j.numecd.2012.12.005. Epub 2013 Feb 23.

  • Penn L, White M, Lindstrom J, den Boer AT, Blaak E, Eriksson JG, Feskens E, Ilanne-Parikka P, Keinanen-Kiukaanniemi SM, Walker M, Mathers JC, Uusitupa M, Tuomilehto J. Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT. PLoS One. 2013;8(2):e57143. doi: 10.1371/journal.pone.0057143. Epub 2013 Feb 25.

  • Roumen C, Feskens EJ, Corpeleijn E, Mensink M, Saris WH, Blaak EE. Predictors of lifestyle intervention outcome and dropout: the SLIM study. Eur J Clin Nutr. 2011 Oct;65(10):1141-7. doi: 10.1038/ejcn.2011.74. Epub 2011 May 18.

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ellen E Blaak, PhD

    Maastricht University, Department of Human Biology

    PRINCIPAL INVESTIGATOR
  • Wim HM Saris, PhD

    Maastricht University, Department of Human Biology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

February 1, 1999

Study Completion

June 1, 2006

Last Updated

November 9, 2016

Record last verified: 2006-09