Interval-training and Appetite Regulation in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Interval-training and Appetite Regulation in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02592616
• Other study ID #: H-15008542
• Status: Active, not recruiting
• Phase: N/A
• First received: October 28, 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

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.

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• CON
No exercise intervention.
• CW
One hour of continuous walking on a treadmill.
• IW
One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.

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	Ad-libitum meal energy intake	Subjects will receive a standardized ad-libitum meal and energy intake will be assessed	Initiated 3 hours after the intervention	No
Secondary	Free-living energy intake	Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed.	For 32 hours following the ad-libitum meal.	No
Secondary	Appetite-related hormones	Appetite-related hormones (insulin, ghrelin, leptin, cholecyctokinin, PYY) will be analysed in blood samples collected regularly during the liquid mixed-meal tolerance test following the intervention	Regularly during the 3 hours following the intervention	No
Secondary	Satiety	Satiety questionaires will be completed at regular intervals after the intervention	Regular assessments for 36 hours following the intervention	No