Optimization of Interval-training in Patients With Type 2 Diabetes

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: IW-45; Behavioral: CON; Behavioral: IW-60

• Registration Number: NCT02601482
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-10
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Time-reduced Interval Walking (IW-45)	IW-45	Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill
Control (CON)	CON	No exercise intervention.
Normal Interval Walking (IW-60).	IW-60	Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill

Primary Outcome Measures

Name	Time	Method
Glycemic control	Within the first 4 hours after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Stumvoll insulin sensitivity index	Within the first 4 hours after the intervention	From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.
Cederholm insulin sensitivity index	Within the first 4 hours after the intervention	From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.
Matsuda insulin sensitivity index	Within the first 4 hours after the intervention	From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.
HOMA-2 insulin resistance index	Within the first 4 hours after the intervention	From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed.

Trial Locations

Locations (1)

Center for Physical Activity Research (CFAS); 🇩🇰 Copenhagen, Denmark