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Completed

NCT Number: NCT01991769

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Forskningsposten, St Olavs Hospital, Trondheim, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

47 min moderate intensity training

Behavioral

exercise healthy volunteers

Behavioral

control; no exercise training

Behavioral

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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