Interval-training in Type 2 Diabetics

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02320526
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Primary Completion: 2016-02
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glycemic control	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.

Secondary Outcome Measures

Name	Time	Method
Urinary isoprostanes as a measure of systemic inflammation	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.
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	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.

Trial Locations

Locations (1)

The Centre for Physical Activity Research, Rigshospitalet; 🇩🇰 Copenhagen, Denmark