Acute Exercise and Glucose Tolerance
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Contact: Sine H Knudsen, can.scient. | (+45)35450699 | study.cim@gmail.com |
| Denmark | |
| Centre of Inflammation and Metabolism, Rigshospitalet | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Sine H Knudsen, Can.scient (+45)35450699 study.cim@gmail.com | |
| 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