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Optimization of Interval-training in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CON
IW-60
IW-45
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Glycemic control, exercise, Interval Training

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • BMI > 25

Exclusion Criteria:

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

Sites / Locations

  • Center for Physical Activity Research (CFAS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control (CON)

Normal Interval Walking (IW-60).

Time-reduced Interval Walking (IW-45)

Arm Description

No exercise intervention.

Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill

Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Matsuda insulin sensitivity index
From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.
Stumvoll insulin sensitivity index
From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.
Cederholm insulin sensitivity index
From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.
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.

Full Information

First Posted
November 4, 2015
Last Updated
June 21, 2016
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02601482
Brief Title
Optimization of Interval-training in Patients With Type 2 Diabetes
Official Title
Optimization of Interval-training in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Glycemic control, exercise, Interval Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (CON)
Arm Type
Experimental
Arm Description
No exercise intervention.
Arm Title
Normal Interval Walking (IW-60).
Arm Type
Experimental
Arm Description
Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill
Arm Title
Time-reduced Interval Walking (IW-45)
Arm Type
Experimental
Arm Description
Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill
Intervention Type
Behavioral
Intervention Name(s)
CON
Intervention Type
Behavioral
Intervention Name(s)
IW-60
Intervention Type
Behavioral
Intervention Name(s)
IW-45
Primary Outcome Measure Information:
Title
Glycemic control
Description
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.
Time Frame
Within the first 4 hours after the intervention
Secondary Outcome Measure Information:
Title
Matsuda insulin sensitivity index
Description
From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.
Time Frame
Within the first 4 hours after the intervention
Title
Stumvoll insulin sensitivity index
Description
From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.
Time Frame
Within the first 4 hours after the intervention
Title
Cederholm insulin sensitivity index
Description
From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.
Time Frame
Within the first 4 hours after the intervention
Title
HOMA-2 insulin resistance index
Description
From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed.
Time Frame
Within the first 4 hours after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes Mellitus BMI > 25 Exclusion Criteria: Pregnancy Smoking Contraindication to increased levels of physical activity Eating disorder Insulin dependence
Facility Information:
Facility Name
Center for Physical Activity Research (CFAS)
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Optimization of Interval-training in Patients With Type 2 Diabetes

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