Impact of 3-Year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study - Full Text View

Sponsor:	Maastricht University
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00381186

Purpose

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).

Condition	Intervention
Impaired Glucose Tolerance Type 2 Diabetes	Behavioral: diet- and exercise intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Impact of 3-Year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Exercise and Physical Fitness

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

2-hour glucose levels
insulin resistance

Secondary Outcome Measures:

adherence
type 2 diabetes
dietary intake change
exercise change

Estimated Enrollment:	150
Study Start Date:	February 1999
Estimated Study Completion Date:	June 2006

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

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381186

Sponsors and Collaborators

Maastricht University

Investigators

Principal Investigator:	Ellen E Blaak, PhD	Maastricht University, Department of Human Biology
Study Chair:	Wim HM Saris, PhD	Maastricht University, Department of Human Biology

More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 May 18.

ClinicalTrials.gov Identifier:	NCT00381186 History of Changes
Other Study ID Numbers:	NWO 2200.0139, ZonMW 940-35-034, DFN 98.901 and 2000.00.020
Study First Received:	September 25, 2006
Last Updated:	September 25, 2006
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:

impaired glucose tolerance
type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on February 09, 2012