Physical Training and the Incretin Effect (EXINT2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Taulo Lund, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01698502
First received: September 26, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

It is well known that continuous physical exercise leads to a number of changes in the body. Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases. Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity in primarily in muscle, but also in the liver increase.

Also endocrine glands adapts according to the level of physical activity. It is known that in healthy, younger people the insulin secretion from the pancreas after administration of sugar consumed orally or given directly into a vein, is significantly lower in trained individuals compared with untrained. This change does, however, not only apply to glucose, as also stimulation by the amino acid arginine, shows the same pattern.

It seems plausible that the endocrine glands/cells adapts to the level of physical training, but this has not yet been investigated.

The gastrointestinal tract is the birthplace of a variety of hormones. One group of these is called incretin hormones. They stimulate the glucose dependant insulin secretion in the pancreas and affect hunger/satiety. Whether the incretin production and thus their concentration in the blood is regulated by physical training is unknown.

Obese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin sensitivity. As a consequence their (type 2 diabetics, at least early in their disease course) meal stimulated insulin release is greater than in healthy, normal weight individuals. This in spite of the fact that the incretin effect is reduced in obese people and patients with type 2 diabetes compared to healthy, normal weight.

Whether physical training affects both the secretion of incretins and the incretin effect has not yet been studied.

The purpose of this study is to investigate whether incretin hormones in physical well-trained young men have a changed effect on insulin secretion from the pancreas compared to untrained young men. A difference may indicate that the body's endocrine glands adapts to training mode.

The investigators hypothesis is that incretin hormones have a decreased effect on the glucose dependant insulin release in physically trained persons and thus results in a lower insulin release at any given plasma glucose level.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Does Physical Training Effect the Incretin Effect

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Incretin effect [ Time Frame: Test day 1 and 2 within 7 days. ] [ Designated as safety issue: No ]
    The Incretin effect is measured on two separate days as the difference between the insulin secretion after an OGTT (day 1) compared to an IGII (day 2) where the plasma glucose curve mirrors the one on the OGTT day.


Secondary Outcome Measures:
  • Hormone responses [ Time Frame: Test day 1 and 2 within 7 days. ] [ Designated as safety issue: No ]
    Measurements of the release of gut hormone plasma concentrations during OGTT and IGII (baseline, 15, 30, 45, 60, 90, 150, 210 min.


Biospecimen Retention:   Samples Without DNA

Human plasma samples.


Enrollment: 21
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Trained
Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
Untrained
Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Danish University Students from University of Copenhagen,

Criteria

Inclusion Criteria:

  • Sedentary: 50>VO2max, ml*min-1*kg-1 OR endurance trained VO2max, ml*min-1*kg-1>60
  • 20-30 years
  • BMI: 18,5-25kg/m2
  • Caucasian
  • Healthy

Exclusion Criteria:

  • Any kind of medication or diabetes in the family (parents, siblings),
  • Non-caucasian
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698502

Locations
Denmark
University of Copenhagen, Faculty of Health Sciences
Copenhagen, North, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
Study Chair: Flemming Dela, Prof. MD University of Copenhagen, Dep. of Biomedical Sciences, Center of healthy Ageing, XLAB
  More Information

Publications:

Responsible Party: Michael Taulo Lund, MD. PhD. Student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01698502     History of Changes
Other Study ID Numbers: EXINT2_FD
Study First Received: September 26, 2012
Last Updated: June 19, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Incretin
Training
Glucagon like peptide
glucose dependent insulinotropic peptide
Gut
Exercise
Insulin
Focus:
Gut hormone
adaptations

Additional relevant MeSH terms:
Gastric Inhibitory Polypeptide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014