Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments con, cw, iw
Sponsor Rigshospitalet, Denmark
Start date October 2015
End date June 2016
Trial size 14 participants
Trial identifier NCT02592616, H-15008542

Summary

Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear.

This study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise.

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 interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)

3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.

After the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Control (CON).
con
No exercise intervention.
(Experimental)
Continuous Walking (CW).
cw
One hour of continuous walking on a treadmill.
(Experimental)
Interval Walking (IW).
iw
One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.

Primary Outcomes

Measure
Ad-libitum meal energy intake
time frame: Initiated 3 hours after the intervention

Secondary Outcomes

Measure
Free-living energy intake
time frame: For 32 hours following the ad-libitum meal.
Appetite-related hormones
time frame: Regularly during the 3 hours following the intervention
Satiety
time frame: Regular assessments for 36 hours following the intervention

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: - Type 2 Diabetes Mellitus - BMI > 25 Exclusion Criteria: - Pregnancy - Smoking - Contraindication to increased levels of physical activity - Eating disorder - Insulin dependence

Additional Information

Official title Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.