Acute Exercise and Glucose Tolerance

This study is currently recruiting participants.
Verified February 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01540097
First received: February 22, 2012
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

Type 2 diabetes mellitus (T2DM) is characterised by insulin resistance and impaired glucose tolerance. The role of beta-cell dysfunction in the progression of this disease has become increasingly accepted, why prevention and reversal of this dysfunction is key in reversing T2DM. Lifestyle interventions including exercise training can improve insulin sensitivity in healthy and T2DMs. However, the specific exercise-derived effects on beta-cells and glucose tolerance are not fully understood. So, the main purpose is to investigate the effects of exercise on glucose tolerance in both healthy male subjects (NGT), subjects with impaired glucose tolerance (IGT) or with T2DM.

Subjects will be screened and undergo measures of body composition (DXA-scan), maximal aerobic capacity (VO2max) and maximal power output (Watt max). Subjects will withhold any oral antidiabetic as well as cholesterol and/or blood pressure lowering medication for 3 days prior to testing. On two separate occasions 24 male subjects (NGT n=8, IGT n=8, T2DM n=8) will undergo a 3-hour oral glucose tolerance test (OGTT) after an hour of exercise (EX) and rest (CON). Blood is drawn at baseline and every 10th minutes from 30 minutes into the exercise bout and throughout the OGTT to measure glucose, insulin and c-peptide. The exercise will be performed on a bike cycle ergometer at 50% of Watt max. Insulin secretion rates (ISR; pmol/min) in response to glucose will be deconvoluted from peripheral blood C-peptide concentrations using standard parameters for C-peptide clearance.

End points:

Effects of 1 hour of exercise on:

  • glucose tolerance measured by OGTT
  • beta-cell function expressed as ISR during OGTT

Condition Intervention Phase
Exercise in Pre-diabetic and Type 2 Diabetic Subjects
Behavioral: 1-hour of exercise
Behavioral: Rest (control)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Acute Exercise on Glucose Tolerance in NGT, IGT and T2DM Male Subjects

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Oral glucose tolerance [ Time Frame: during 3 hours following exercise/rest ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
1 hour bike ride at moderate intensity
Behavioral: 1-hour of exercise
A single hour bike exercise at 50% of individual Watt max
Experimental: Rest
1 hour bed rest
Behavioral: Rest (control)
1 hour of rest as control to the exercise "Arm"

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, IGT or T2DM
  • BMI 25-40 kg/m2
  • Physically active < 2.5 h/week.

Exclusion Criteria:

  • Weight instability (> 5 kg change during the last 6 month)
  • Chronic disease of heart, lungs, kidneys, liver
  • Smoking
  • Contra-indication to exercise; insulin-treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540097

Contacts
Contact: Sine H Knudsen, can.scient. (+45)35450699 study.cim@gmail.com

Locations
Denmark
Centre of Inflammation and Metabolism, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Sine H Knudsen, Can.scient     (+45)35450699     study.cim@gmail.com    
Sponsors and Collaborators
Inge Holm
Investigators
Study Director: Bente K Pedersen, Professor Centre of Inflammation and Metabolism, Rigshospitalet
  More Information

No publications provided

Responsible Party: Inge Holm, CIM administrator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01540097     History of Changes
Other Study ID Numbers: OGTTex
Study First Received: February 22, 2012
Last Updated: February 27, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013