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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
47 min moderate intensity training
exercise healthy volunteers
control; no exercise training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring exercise, endothelium, postprandial period

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forskningsposten, St Olavs Hospital
  • ISB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

exercise diabetes type 2

exercise healthy volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 28, 2013
Last Updated
June 13, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01991769
Brief Title
Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
Official Title
Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
exercise, endothelium, postprandial period

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise diabetes type 2
Arm Type
Experimental
Arm Description
4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.
Arm Title
exercise healthy volunteers
Arm Type
Active Comparator
Arm Description
4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.
Intervention Type
Behavioral
Intervention Name(s)
47 min moderate intensity training
Intervention Type
Behavioral
Intervention Name(s)
exercise healthy volunteers
Intervention Type
Behavioral
Intervention Name(s)
control; no exercise training
Primary Outcome Measure Information:
Title
endothelial function
Description
measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte B Ingul, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Forskningsposten, St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
ISB
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26272328
Citation
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.
Results Reference
result

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

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