The Acute Effect of Interval-walking

Type 2 Diabetes Mellitus Clinical Trial

— acute IWS  

Official title:

The Acute Effect of Interval-walking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987258
• Other study ID #: H-3-2012-141
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: February 26, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Four months of interval walking training (IWT) is superior to energy-expenditure matched continuous walking training (CWT) with regards to weight loss and improvements in glycemic control. The reason for this is unclear. One potential explanation for the differential outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as the elevated oxygen consumption measured during the hours following an exercise bout. A large EPOC means greater energy expenditure which, if energy intake does not change, leads to a greater weight loss. This weight loss may subsequently improve glycemic control

• Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic control in type 2 diabetics and to assess mechanisms responsible for differences (if any). It is hypothesised that IWT will be more advantageous for improving glycemic control.

• Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC. It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus, type 2

Exclusion Criteria:

• Smoking

• Pregnancy

• insulin dependence

• Contraindication to physical activity (as judged by medical history and screening)

• Evidence of thyroid, liver, lung, kidney or heart disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Interval Walking

• Continuous walking

Locations

Country	Name	City	State
Denmark	Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Glycemic control will be assessed after a one hour specific exercise intervention (control/continuous walking/interval walking) in a controlled setting (a mixed meal tolerance test). Moreover, glycemic control will be assessed during the following 2 days in a free-living environment, using continuous glucose monitoring systems.	Will be assessed immediately after the intervention using a mixed meal tolerance test (duration: 5 hours) followed by continuous glucose monitoring (duration: 48 hours).	No
Secondary	Excess post-exercise oxygen consumption (EPOC)	EPOC will be assessed during the hours following the before-mentioned specific exercise bouts using the indirect calorimetry ventilated hood technique.	Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).	No