Interval-training in Type 2 Diabetics

April 26, 2016 updated by: Anders Rasmussen Rinnov, Rigshospitalet, Denmark

Interval-training in Type 2 Diabetics - Mechanisms Behind Increased Glucose Disposal and Effects on Systemic Inflammation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • The Centre for Physical Activity Research, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Control intervention: Subjects will continue their life unaltered during the 14 days intervention period
Behavioral: Control
Other Names:
  • CON
Experimental: Continuous walking
Training intervention: Subjects will perform continuous walking for one hour per day at every weekday during the 14 days intervention period
Behavioral: Continuous walking
Other Names:
  • CWT
Experimental: Interval Walking
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
Behavioral: Interval walking
Other Names:
  • IWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Change from baseline at 14 days
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.
Change from baseline at 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary isoprostanes as a measure of systemic inflammation
Time Frame: Change from baseline at 14 days
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.
Change from baseline at 14 days
Rate of dissappearance during a 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp, as a measure of glucose effectiveness + insulin sensitivity
Time Frame: Change from baseline at 14 days
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.
Change from baseline at 14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting energy expenditure and respiratory exchange rate
Time Frame: Change from baseline at 14 days
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.
Change from baseline at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Kristian Karstoft, MD, PhD, Rigshospitalet, The Centre for Physical Activity Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-6-2014-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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