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

Tracking Information

First Received Date ^ICMJE

September 25, 2006

Last Updated Date

September 25, 2006

Start Date ^ICMJE

February 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

2-hour glucose levels
insulin resistance

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

adherence
type 2 diabetes
dietary intake change
exercise change

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Impaired Glucose Tolerance
Type 2 Diabetes

Intervention ^ICMJE

Behavioral: diet- and exercise intervention

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00381186

Responsible Party

Study ID Numbers ^ICMJE

NWO 2200.0139, ZonMW 940-35-034, DFN 98.901 and 2000.00.020

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Maastricht University Medical Center

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP