NCT01991769

Brief Summary

The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function. Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

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

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

October 28, 2013

Last Update Submit

June 13, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

exerciseendotheliumpostprandial period

Outcome Measures

Primary Outcomes (1)

  • endothelial function

    measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines

    24 hours

Study Arms (2)

exercise diabetes type 2

EXPERIMENTAL

4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.

Behavioral: 47 min moderate intensity trainingBehavioral: exercise healthy volunteersBehavioral: control; no exercise training

exercise healthy volunteers

ACTIVE COMPARATOR

4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.

Behavioral: 47 min moderate intensity trainingBehavioral: exercise healthy volunteersBehavioral: control; no exercise training

Interventions

47 min moderate intensity trainingBEHAVIORAL
exercise diabetes type 2exercise healthy volunteers
exercise healthy volunteersBEHAVIORAL
exercise diabetes type 2exercise healthy volunteers
control; no exercise trainingBEHAVIORAL
exercise diabetes type 2exercise healthy volunteers

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy or type 2 diabetes

You may not qualify if:

  • type 2 diabetes more than 10 years
  • unstable angina
  • myocardial infarction
  • overt cardiovascular disease.
  • severe valvular disease.
  • overt lung disease.
  • orthopedical- /neurological restrictions
  • severe disease related to diabetes type 2 (neuropathy, micro-or macroalbuminuria, retinopathy)
  • body mass index \>35
  • severe eating disorders.
  • personality disturbances.
  • planned surgery during the project period.
  • patients who achieve greater than the current exercise guidelines for type 2 diabetes (210 min/week) before the start of the study.
  • uncontrolled hypertension
  • kidney failure
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Forskningsposten, St Olavs Hospital

Trondheim, Norway

Location

ISB

Trondheim, Norway

Location

Related Publications (1)

  • Hollekim-Strand SM, Malmo V, Follestad T, Wisloff U, Ingul CB. Fast food increases postprandial cardiac workload in type 2 diabetes independent of pre-exercise: A pilot study. Nutr J. 2015 Aug 14;14:79. doi: 10.1186/s12937-015-0069-1.

    PMID: 26272328RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Charlotte B Ingul, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 25, 2013

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

November 1, 2013

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

NO(2)