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: March 24, 2014
Last verified: March 2014
  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 (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP)) [ Time Frame: Test day 1 and 2 within 7 days. ] [ Designated as safety issue: No ]
    The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.


Secondary Outcome Measures:
  • The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP). [ Time Frame: Test day 1 and 2 within 7 days. ] [ Designated as safety issue: No ]
    Comparison of the total release of GIP during the 3 hour OGTT and IIGI.


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 (Maximal oxygen uptake (VO2max), ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
Untrained
Healthy, sedentary (Maximal oxygen uptake (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>Maximal oxygen uptake (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 10, 2013
Last Updated: March 24, 2014
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:
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014