Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training

June 13, 2016 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Forskningsposten, St Olavs Hospital
      • Trondheim, Norway
        • ISB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy or type 2 diabetes

Exclusion Criteria:

  • 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
  • cardiomyopathy
  • smoking
  • patients who probably not will be able to complete the study
  • alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise diabetes type 2
4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.
Behavioral: 47 min moderate intensity training
Behavioral: exercise healthy volunteers
Behavioral: control; no exercise training
Active Comparator: exercise healthy volunteers
4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.
Behavioral: 47 min moderate intensity training
Behavioral: exercise healthy volunteers
Behavioral: control; no exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial function
Time Frame: 24 hours
measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Charlotte B Ingul, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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