Back to resultsImpact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study
Primary Purpose
Impaired Glucose Tolerance, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diet- and exercise intervention
Sponsored by
About this trial
This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring impaired glucose tolerance, type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
2-hour glucose levels
insulin resistance
Secondary Outcome Measures
adherence
type 2 diabetes
dietary intake change
exercise change
Full Information
NCT ID
NCT00381186
First Posted
September 25, 2006
Last Updated
November 8, 2016
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00381186
Brief Title
Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study
Official Title
Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
5. Study Description
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).
Detailed Description
Objective 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).
Research design and methods 147 IGT subjects (75 male, 72 female) were randomized to the intervention group (INT) or control group (CON). 106 subjects (52 INT, 54 CON) completed 3 years of intervention. Annually, glucose, insulin and FFA concentrations were determined during fasting and after an oral glucose tolerance test, in addition to measurements of body weight, serum lipids, blood pressure and maximal aerobic capacity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Type 2 Diabetes
Keywords
impaired glucose tolerance, type 2 diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet- and exercise intervention
Primary Outcome Measure Information:
Title
2-hour glucose levels
Title
insulin resistance
Secondary Outcome Measure Information:
Title
adherence
Title
type 2 diabetes
Title
dietary intake change
Title
exercise change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen E Blaak, PhD
Organizational Affiliation
Maastricht University, Department of Human Biology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wim HM Saris, PhD
Organizational Affiliation
Maastricht University, Department of Human Biology
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
23462149
Citation
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.
Results Reference
derived
PubMed Identifier
23451166
Citation
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.
Results Reference
derived
PubMed Identifier
21587283
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study
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