Diabetes Prevention in Clinical Practice. (DIAVIP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01834378
First received: April 15, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention
Type 2 Diabetes
Behavioral: Low intensity intervention
Behavioral: High intensity intervention.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • HOMA IR [ Time Frame: 12 months after inclusion (baseline) ] [ Designated as safety issue: No ]
    Insulin resistance according to HOMA


Estimated Enrollment: 2000
Study Start Date: July 2014
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01834378     History of Changes
Other Study ID Numbers: DIAVIP-1204, Swedish Research Council
Study First Received: April 15, 2013
Last Updated: May 5, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:
diabetes
insulin resistance
exercise

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014