Clinical trial NCT02320526: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Training
Interval training
Systemic inflammation
Glucose disposal
Insulin sensitivity
Glucose effectiveness
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Glycemic control
timeFrame: Change from baseline at 14 days
Secondary outcomes:
measure: Urinary isoprostanes as a measure of systemic inflammation
timeFrame: Change from baseline at 14 days
measure: Rate of dissappearance during a 2-step (pancreatic + hyperinsulinemic) hyperglycemic clamp, as a measure of glucose effectiveness + insulin sensitivity
timeFrame: Change from baseline at 14 days
Other outcomes:
measure: Resting energy expenditure and respiratory exchange rate
timeFrame: Change from baseline at 14 days
Locations:
city: Copenhagen
country: Denmark
facility: The Centre for Physical Activity Research, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, The Centre for Physical Activity Research
name: Kristian Karstoft, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.