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Impaired Glucose ToleranceNCT00381186

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

A study testing diet- and exercise intervention in people with Impaired Glucose Tolerance and Type 2 Diabetes, run by Maastricht University Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Impaired Glucose Tolerance, Type 2 Diabetes
What is being tested?
diet- and exercise intervention
How many people
150 participants
Where
No sites listed yet
Study dates
Feb 1999to Jun 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8

Who cannot join

  • 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

About this study

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).

Read the 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.

Being tested
diet- and exercise intervention
Keywords
impaired glucose tolerance, type 2 diabetes
Medical subject headings
Glucose Intolerance, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diet- and exercise interventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-hour glucose levels

  2. insulin resistance

Secondary outcomes (4)

  1. adherence

  2. type 2 diabetes

  3. dietary intake change

  4. exercise change

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2006 (estimated)
  2. Study startFeb 1999
  3. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00381186
Sponsor's protocol ID
NWO 2200.0139
Other IDs
ZonMW 940-35-034, DFN 98.901 and 2000.00.020
Status last verified
Sep 2006
First submitted
25 Sep 2006
Last updated
9 Nov 2016
Results posted
No

Publications

  • 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.

    PubMed 23462149

  • 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.

    PubMed 23451166

  • 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.

    PubMed 21587283

Questions about this trial

What is this clinical trial studying?

A study testing diet- and exercise intervention in people with Impaired Glucose Tolerance and Type 2 Diabetes, run by Maastricht University Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-hour glucose levels. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00381186, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.

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