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Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study

NCT ID: NCT00381186

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Impaired Glucose Tolerance Type 2 Diabetes

Keywords

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impaired glucose tolerance type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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diet- and exercise intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Ellen E Blaak, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, Department of Human Biology

Wim HM Saris, PhD

Role: STUDY_CHAIR

Maastricht University, Department of Human Biology

References

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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.

Reference Type DERIVED
PMID: 23462149 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23451166 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21587283 (View on PubMed)

Other Identifiers

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ZonMW 940-35-034

Identifier Type: -

Identifier Source: secondary_id

DFN 98.901 and 2000.00.020

Identifier Type: -

Identifier Source: secondary_id

NWO 2200.0139

Identifier Type: -

Identifier Source: org_study_id