Optimization of Interval-training in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Optimization of Interval-training in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02601482
• Other study ID #: H-15008542 - 2
• Status: Active, not recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: June 21, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• 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 time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important.

This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration.

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

1. Sixty minutes of rest (CON)

2. Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)

3. Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45).

After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus

• BMI > 25

Exclusion Criteria:

• Pregnancy

• Smoking

• Contraindication to increased levels of physical activity

• Eating disorder

• Insulin dependence

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• CON

• IW-60

• IW-45

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 assessed 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 intervention	No
Secondary	Matsuda insulin sensitivity index	From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.	Within the first 4 hours after the intervention	No
Secondary	Stumvoll insulin sensitivity index	From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.	Within the first 4 hours after the intervention	No
Secondary	Cederholm insulin sensitivity index	From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.	Within the first 4 hours after the intervention	No
Secondary	HOMA-2 insulin resistance index	From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed.	Within the first 4 hours after the intervention	No