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Completed

NCT Number: NCT02320526

Interval-training in Type 2 Diabetics

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Centre for Physical Activity Research, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

Other names: CON

Continuous walking

Behavioral

Other names: CWT

Interval Walking

Behavioral

Other names: IWT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2014
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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