Interval-training in Type 2 Diabetics

NCT02320526 | Completed

• 1 other identifier: H-6-2014-043
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Exercise; Training; Interval training; Systemic inflammation; Glucose disposal; Insulin sensitivity; Glucose effectiveness

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at 14 days

Secondary Outcomes (2)

• Urinary isoprostanes as a measure of 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

  Change from baseline at 14 days

Other Outcomes (1)

• Resting energy expenditure and respiratory exchange rate

  Change from baseline at 14 days

Study Arms (3)

Control

EXPERIMENTAL

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

Behavioral: Control

Continuous walking

EXPERIMENTAL

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

Behavioral: Continuous walking

Interval Walking

EXPERIMENTAL

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

Interventions

Control BEHAVIORAL

Also known as: CON

Control

Continuous walking BEHAVIORAL

Also known as: CWT

Continuous walking

Interval walking BEHAVIORAL

Also known as: IWT

Interval Walking

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

The Centre for Physical Activity Research, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (3)

• 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.

  PMID: 28842722 DERIVED

• 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.

  PMID: 28659869 DERIVED

• 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.

  PMID: 27942800 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Hyperinsulinism

Study Officials

• Kristian Karstoft, MD, PhD

  Rigshospitalet, The Centre for Physical Activity Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 19, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

DK (1)