- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway
- Forskningsposten, St Olavs Hospital
-
Trondheim, Norway
- ISB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
|
Active Comparator: exercise healthy volunteers
4x4 min interval training, 47 min moderate intensity training, or no exercise preceding an 'unhealthy' meal.
|
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
Collaborators
Investigators
- Study Director: Charlotte B Ingul, PhD, Norwegian University of Science and Technology
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Newsoara Biopharma Co., Ltd.RecruitingT2DM (Type 2 Diabetes Mellitus)China
-
Shanghai Golden Leaf MedTec Co. LtdActive, not recruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on 47 min moderate intensity training
-
Riphah International UniversityCompleted
-
Hasselt UniversityKU Leuven; Maastricht UniversityRecruitingLow Back Pain | Chronic Pain | Chronic Low-back PainBelgium
-
Universiti Putra MalaysiaCompletedHealthy AgingMalaysia
-
Riphah International UniversityRecruitingPsychological Well-BeingPakistan
-
Norwegian University of Science and TechnologyCompleted
-
Sunnaas Rehabilitation HospitalCompleted
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
National Taiwan University HospitalUnknownPhysical Activity | Exercise | Metabolic Syndrome XTaiwan
-
Rigshospitalet, DenmarkCompleted