Interval-training in Type 2 Diabetics

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320526
• Other study ID #: H-6-2014-043
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: April 26, 2016
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Control

• Continuous walking

• Interval walking

Locations

Country	Name	City	State
Denmark	The Centre for Physical Activity Research, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting energy expenditure and respiratory exchange rate	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	No
Primary	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	No
Secondary	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.	Change from baseline at 14 days	No
Secondary	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.	Change from baseline at 14 days	No