Clinical trial NCT00381186: 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
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Type 2 Diabetes
Keywords: impaired glucose tolerance
type 2 diabetes
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2006-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 2-hour glucose levels
measure: insulin resistance
Secondary outcomes:
measure: adherence
measure: type 2 diabetes
measure: dietary intake change
measure: exercise change
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University, Department of Human Biology
name: Ellen E Blaak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University, Department of Human Biology
name: Wim HM Saris, PhD
role: STUDY_CHAIR
References:
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.
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.
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.