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Interval-training in Type 2 Diabetics

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Control
Continuous walking
Interval walking
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 Exercise, Training, Interval training, Systemic inflammation, Glucose disposal, Insulin sensitivity, Glucose effectiveness

Eligibility Criteria

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

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • BMI >18 but <40 kg/m2

Exclusion Criteria:

  • Pregnancy
  • Smoking
  • Contraindication to increased levels of physical activity
  • More than moderate levels of physical activity (>90 min/week) of maximally moderate intensity
  • Insulin dependence
  • Thyroid, liver, lung, heart or kidney disease, with the need for treatment

Sites / Locations

  • The Centre for Physical Activity Research, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Continuous walking

Interval Walking

Arm Description

Control intervention: Subjects will continue their life unaltered during the 14 days intervention period

Training intervention: Subjects will perform continuous walking for one hour per day at every weekday during the 14 days intervention period

Training intervention: Subjects will perform interval walking for one hour per day at every weekday during the 14 days intervention period. Interval walking will be performed as repeated cycles of three minutes of slow and hree minutes of fast walking during the entire training session

Outcomes

Primary Outcome Measures

Glycemic control
Glycemic control incl. glycemic variability and -spikes, will be measured with continuous glucose monitoring over 24 hours during standardized dietary intake before and after each intervention.

Secondary Outcome Measures

Urinary isoprostanes as a measure of systemic inflammation
Systemic inflammation will be measured as isoprostanes in urine collected over 24 hours. The changes in glycemic control (Outcome 1), will be correlated with the changes in systemic inflammation.
Rate of dissappearance during a 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp, as a measure of glucose effectiveness + insulin sensitivity
A 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp will be performed before and after each intervention, to assess the mechanisms behind the intervention-induced improvements in glycemic control. In this way, the intervention-induced effects on glucose effectiveness and insulin sensitivity will be assessed.

Full Information

First Posted
December 8, 2014
Last Updated
April 26, 2016
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02320526
Brief Title
Interval-training in Type 2 Diabetics
Official Title
Interval-training in Type 2 Diabetics - Mechanisms Behind Increased Glucose Disposal and Effects on Systemic Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

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
Interval training is superior to continuous training for improving glycemic control, hereunder glycemic variability and -spikes. However, the underlying mechanisms and the clinical impact is at present unknown. The overall objective of this project is to determine the mechanisms underlying aeroic interval-training-induced reductions in glycemic variability and -spikes, and the impact on levels of systemic inflammation in type 2 diabetes patients. It is hypothesized that aerobic interval training reduces glycemic variability and -spikes more than continuous training due to larger improvements in both peripheral insulin sensitivity and the mass action effect of glucose. Moreover, it is hypothesized that these reductions in glycemic variability and -spikes also reduces systemic inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Exercise, Training, Interval training, Systemic inflammation, Glucose disposal, Insulin sensitivity, Glucose effectiveness

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Control intervention: Subjects will continue their life unaltered during the 14 days intervention period
Arm Title
Continuous walking
Arm Type
Experimental
Arm Description
Training intervention: Subjects will perform continuous walking for one hour per day at every weekday during the 14 days intervention period
Arm Title
Interval Walking
Arm Type
Experimental
Arm Description
Training intervention: Subjects will perform interval walking for one hour per day at every weekday during the 14 days intervention period. Interval walking will be performed as repeated cycles of three minutes of slow and hree minutes of fast walking during the entire training session
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
CON
Intervention Type
Behavioral
Intervention Name(s)
Continuous walking
Other Intervention Name(s)
CWT
Intervention Type
Behavioral
Intervention Name(s)
Interval walking
Other Intervention Name(s)
IWT
Primary Outcome Measure Information:
Title
Glycemic control
Description
Glycemic control incl. glycemic variability and -spikes, will be measured with continuous glucose monitoring over 24 hours during standardized dietary intake before and after each intervention.
Time Frame
Change from baseline at 14 days
Secondary Outcome Measure Information:
Title
Urinary isoprostanes as a measure of systemic inflammation
Description
Systemic inflammation will be measured as isoprostanes in urine collected over 24 hours. The changes in glycemic control (Outcome 1), will be correlated with the changes in systemic inflammation.
Time Frame
Change from baseline at 14 days
Title
Rate of dissappearance during a 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp, as a measure of glucose effectiveness + insulin sensitivity
Description
A 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp will be performed before and after each intervention, to assess the mechanisms behind the intervention-induced improvements in glycemic control. In this way, the intervention-induced effects on glucose effectiveness and insulin sensitivity will be assessed.
Time Frame
Change from baseline at 14 days
Other Pre-specified Outcome Measures:
Title
Resting energy expenditure and respiratory exchange rate
Description
Resting indirect calorimetry measurements will be performed before and after each intervention, to assess the effects of the interventions on resting energy-expenditure and respiratory exchange rates.
Time Frame
Change from baseline at 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus BMI >18 but <40 kg/m2 Exclusion Criteria: Pregnancy Smoking Contraindication to increased levels of physical activity More than moderate levels of physical activity (>90 min/week) of maximally moderate intensity Insulin dependence Thyroid, liver, lung, heart or kidney disease, with the need for treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Karstoft, MD, PhD
Organizational Affiliation
Rigshospitalet, The Centre for Physical Activity Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Centre for Physical Activity Research, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28842722
Citation
Karstoft K, Clark MA, Jakobsen I, Knudsen SH, van Hall G, Pedersen BK, Solomon TPJ. Glucose effectiveness, but not insulin sensitivity, is improved after short-term interval training in individuals with type 2 diabetes mellitus: a controlled, randomised, crossover trial. Diabetologia. 2017 Dec;60(12):2432-2442. doi: 10.1007/s00125-017-4406-0. Epub 2017 Aug 25.
Results Reference
derived
PubMed Identifier
28659869
Citation
Karstoft K, Brinklov CF, Thorsen IK, Nielsen JS, Ried-Larsen M. Resting Metabolic Rate Does Not Change in Response to Different Types of Training in Subjects with Type 2 Diabetes. Front Endocrinol (Lausanne). 2017 Jun 13;8:132. doi: 10.3389/fendo.2017.00132. eCollection 2017.
Results Reference
derived
PubMed Identifier
27942800
Citation
Karstoft K, Clark MA, Jakobsen I, Muller IA, Pedersen BK, Solomon TP, Ried-Larsen M. The effects of 2 weeks of interval vs continuous walking training on glycaemic control and whole-body oxidative stress in individuals with type 2 diabetes: a controlled, randomised, crossover trial. Diabetologia. 2017 Mar;60(3):508-517. doi: 10.1007/s00125-016-4170-6. Epub 2016 Dec 9.
Results Reference
derived

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Interval-training in Type 2 Diabetics

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