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

NCT ID: NCT01991769

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise diabetes type 2

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

Group Type EXPERIMENTAL

47 min moderate intensity training

Intervention Type BEHAVIORAL

exercise healthy volunteers

Intervention Type BEHAVIORAL

control; no exercise training

Intervention Type BEHAVIORAL

exercise healthy volunteers

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

Group Type ACTIVE_COMPARATOR

47 min moderate intensity training

Intervention Type BEHAVIORAL

exercise healthy volunteers

Intervention Type BEHAVIORAL

control; no exercise training

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

47 min moderate intensity training

Intervention Type BEHAVIORAL

exercise healthy volunteers

Intervention Type BEHAVIORAL

control; no exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charlotte B Ingul, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Forskningsposten, St Olavs Hospital

Trondheim, , Norway

Site Status

ISB

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26272328 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/1801

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.