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Trial record 45 of 399 for:    PYY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02592616
Recruitment Status : Unknown
Verified June 2016 by Anders Rasmussen Rinnov, Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : June 22, 2016
Information provided by (Responsible Party):
Anders Rasmussen Rinnov, Rigshospitalet, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: CON Behavioral: CW Behavioral: IW Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interval-training and Appetite Regulation in Patients With Type 2 Diabetes
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CON
Control (CON).
Behavioral: CON
No exercise intervention.

Experimental: CW
Continuous Walking (CW).
Behavioral: CW
One hour of continuous walking on a treadmill.

Experimental: IW
Interval Walking (IW).
Behavioral: IW
One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.

Primary Outcome Measures :
  1. Ad-libitum meal energy intake [ Time Frame: Initiated 3 hours after the intervention ]
    Subjects will receive a standardized ad-libitum meal and energy intake will be assessed

Secondary Outcome Measures :
  1. Free-living energy intake [ Time Frame: For 32 hours following the ad-libitum meal. ]
    Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed.

  2. Appetite-related hormones [ Time Frame: Regularly during the 3 hours following the intervention ]
    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

  3. Satiety [ Time Frame: Regular assessments for 36 hours following the intervention ]
    Satiety questionaires will be completed at regular intervals after the intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • BMI > 25

Exclusion Criteria:

  • Pregnancy
  • Smoking
  • Contraindication to increased levels of physical activity
  • Eating disorder
  • Insulin dependence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02592616

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Center for Physical Activity Research (CFAS)
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

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Responsible Party: Anders Rasmussen Rinnov, MD, PhD, Rigshospitalet, Denmark Identifier: NCT02592616     History of Changes
Other Study ID Numbers: H-15008542
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016

Keywords provided by Anders Rasmussen Rinnov, Rigshospitalet, Denmark:
Energy intake

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases