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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Physical Training and the Incretin Effect

Short name EXINT2

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
21 participants (actual)
Sponsor
University of Copenhagen · Other
Design
Not stated
Countries
1 country

Denmark

Start
Aug 2012
Primary completion
Feb 2013
Completion
Jun 2013
First posted
3 Oct 2012 (estimated)
Last update posted
24 Apr 2014 (estimated)
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph –

    EXINT2

    NCT01698502

    Aug 2012 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms2

  • Other

    Trained

    Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml\*min-1\*kg-1\>60), 20-30 year, BMI: 18,5-25kg/m2, males.

  • Other

    Untrained

    Healthy, sedentary (Maximal oxygen uptake (VO2max), ml\*min-1\*kg-1\<50), 20-30 year, BMI: 18,5-25kg/m2, males.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    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 outcomes(1)
  1. 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.

    Registry description

    Comparison of the total release of GIP during the 3 hour OGTT and IIGI.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Test day 1 and 2 within 7 days.

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))

GroupValue (percentage)Spread
Trained724
Untrained673
Secondary and other outcome results(1)
Secondary outcomeMean· Test day 1 and 2 within 7 days.

The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).

GroupValue (pmol/L * 210 min)Spread
Trained3978565
Untrained3819452

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TrainedHealthy, Endurance trained (VO2max, ml\*min-1\*kg-1\>60), 20-30 year, BMI: 18,5-25kg/m2, males.–0 / 110 / 11
UntrainedHealthy, sedentary (VO2max, ml\*min-1\*kg-1\<50), 20-30 year, BMI: 18,5-25kg/m2, males.–0 / 100 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 30 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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