NCT02388113

Brief Summary

This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

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, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

March 9, 2015

Last Update Submit

November 5, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Exercise therapyTime factors

Outcome Measures

Primary Outcomes (1)

  • glycosylated hemoglobin (HbA1c)

    The measured HbA1c level consists of average blood glucose by 50% from the last month, 25% from the previous month, and 25% by the two first previous months. Analysis: standard procedure of St Olavs Hospital.

    12 weeks

Study Arms (2)

accumulated exercise

EXPERIMENTAL

12 exercise sessions of 10 minutes each week, 2 per day, 1 day rest

Behavioral: accumulated exercise

traditional exercise

ACTIVE COMPARATOR

4 exercise sessions of 30 minutes each week, 3 in the training laboratory, 1 at home.

Behavioral: traditional exercise

Interventions

accumulated exerciseBEHAVIORAL
accumulated exercise
traditional exerciseBEHAVIORAL
traditional exercise

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes

You may not qualify if:

  • insulin treatment
  • severe chronic diabetic complications
  • liver dysfunction
  • kidney dysfunction
  • inflammatory diseases
  • heart failure
  • myocardial ischemia
  • major cardiovascular event history
  • physical exercise more than current guidelines for type 2 diabetes
  • inability to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Diagnostic Imaging

Trondheim, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Charlotte Ingul, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 13, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

NO(1)