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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991769
• Other study ID #: 2011/1801
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: June 13, 2016
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 47 min moderate intensity training

• exercise healthy volunteers

• control; no exercise training

Locations

Country	Name	City	State
Norway	Forskningsposten, St Olavs Hospital	Trondheim
Norway	ISB	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Hollekim-Strand SM, Malmo V, Follestad T, Wisløff 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function	measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines	24 hours	No