NCT01834378

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

6.8 years

First QC Date

April 15, 2013

Last Update Submit

August 22, 2016

Conditions

Type 2 Diabetes

Keywords

diabetesinsulin resistanceexercise

Outcome Measures

Primary Outcomes (1)

  • HOMA IR

    Insulin resistance according to HOMA

    12 months after inclusion (baseline)

Study Arms (3)

No intervention

NO INTERVENTION

Low intensity intervention

EXPERIMENTAL
Behavioral: Low intensity intervention

High intensity intervention

EXPERIMENTAL
Behavioral: High intensity intervention.

Interventions

Low intensity interventionBEHAVIORAL

We administer, a pedometer and the participants receive a prescription on physical exercise.

Low intensity intervention
High intensity intervention.BEHAVIORAL

We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.

High intensity intervention

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impaired glucose tolerance
  • Age: 20-85yrs

You may not qualify if:

  • Type2 diabetes
  • Significant disease making life style changes unlikely to happen
  • Unable to communicate in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin ResistanceMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 17, 2013

Study Start

October 1, 2009

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 23, 2016

Record last verified: 2016-08