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Diabetes Prevention in Clinical Practice. (DIAVIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01834378
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.

Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: Low intensity intervention Behavioral: High intensity intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.
Study Start Date : October 2009
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No intervention
Experimental: Low intensity intervention Behavioral: Low intensity intervention
We administer, a pedometer and the participants receive a prescription on physical exercise.
Experimental: High intensity intervention Behavioral: High intensity intervention.
We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.



Primary Outcome Measures :
  1. HOMA IR [ Time Frame: 12 months after inclusion (baseline) ]
    Insulin resistance according to HOMA



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Impaired glucose tolerance
  2. Age: 20-85yrs

Exclusion Criteria:

  1. Type2 diabetes
  2. Significant disease making life style changes unlikely to happen
  3. Unable to communicate in Swedish

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01834378     History of Changes
Other Study ID Numbers: DIAVIP-1204
Swedish Research Council ( Other Grant/Funding Number: Swedish Research Council )
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016

Keywords provided by Göteborg University:
diabetes
insulin resistance
exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases