The Features Behind the Beneficial Effects of Interval-walking

Diabetes Mellitus, Type 2 Clinical Trial

— aIWS2  

Official title:

The Features Behind the Beneficial Effects of Interval-walking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257190
• Other study ID #: H-1-2014-060
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: October 28, 2015
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The reason IW is superior is unknown.

This study will look into whether it is the larger peak intensity during IW or if it is the alternating exercise pattern that is responsible for the larger improvements seen.

Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:

1. One hour of rest (Con)

2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW3)

3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1 min of slow walking; IW1).

After the interventions subjects will undergo a standardized mixed meal tolerance test, with consecutive measurements of blood glucose, insulin and c-peptide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Body mass index > 18 but < 40 m2/kg

• Agreement to pause antidiabetic medication from 2 days before to after each trial

Exclusion Criteria:

• Pregnancy

• Smoking

• Use of exogenous insulin

• Contraindication to increased levels of physical activity

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Control
One hour of rest.
• IW3
A one hour exercise bout with repeated cycles of 3 min of fast and 3 min of slow walking
• IW1
A one hour exercise bout with repeated cycles of 1 min of fast and 1 min of slow walking

Locations

Country	Name	City	State
Denmark	Center for Physical Activity Research (CFAS)	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 measured after each intervention. Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.	Within the first 4 hours after the interventions	No
Secondary	Insulin secretion	Insulin and C-peptide will be measured during the MMTT	Within the first 4 hours after the interventions	No
Secondary	Insulin sensitivity	From the measurements og glucose and insulin during the MMTT, various indices of insulin sensitivity will be assessed	Within the first 4 hours after the interventions	No