HealthyEXINT2NCT01698502
Physical Training and the Incretin Effect
An observational study of Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Danish University Students from University of Copenhagen,
Who may be able to join
- 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
Who cannot join
- Any kind of medication or diabetes in the family (parents, siblings),
- Non-caucasian
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Faculty of Health Sciences
Copenhagen, North, 2200
About this study
Official title: Does Physical Training Effect the Incretin Effect
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.
Read more
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.
- Conditions
- Healthy
- Keywords
- Incretin, Training, Glucagon like peptide, glucose dependent insulinotropic peptide, Gut, Exercise, Insulin, Focus:, Gut hormone, adaptations
- Medical subject headings
- Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
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.
Measured: Test day 1 and 2 within 7 days.
Secondary outcomes (1)
The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).
Comparison of the total release of GIP during the 3 hour OGTT and IIGI.
Measured: Test day 1 and 2 within 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Taulo Lund, University of Copenhagen
- Investigators
- Flemming Dela, Prof. MD, Study chair, University of Copenhagen, Dep. of Biomedical Sciences, Center of healthy Ageing, XLAB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698502
- Sponsor's protocol ID
- EXINT2_FD
- Acronym
- EXINT2
- Status last verified
- Mar 2014
- First submitted
- 26 Sep 2012
- Last updated
- 24 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dela F, Handberg A, Mikines KJ, Vinten J, Galbo H. GLUT 4 and insulin receptor binding and kinase activity in trained human muscle. J Physiol. 1993 Sep;469:615-24. doi: 10.1113/jphysiol.1993.sp019833.
PubMed 8271219Dela F, Mikines KJ, von Linstow M, Secher NH, Galbo H. Effect of training on insulin-mediated glucose uptake in human muscle. Am J Physiol. 1992 Dec;263(6):E1134-43. doi: 10.1152/ajpendo.2006.263.6.E1134.
PubMed 1476187Mikines KJ, Sonne B, Farrell PA, Tronier B, Galbo H. Effect of training on the dose-response relationship for insulin action in men. J Appl Physiol (1985). 1989 Feb;66(2):695-703. doi: 10.1152/jappl.1989.66.2.695.
PubMed 2651385Dela F, Mikines KJ, Von Linstow M, Galbo H. Effect of training on response to a glucose load adjusted for daily carbohydrate intake. Am J Physiol. 1991 Jan;260(1 Pt 1):E14-20. doi: 10.1152/ajpendo.1991.260.1.E14.
PubMed 1987787King DS, Dalsky GP, Staten MA, Clutter WE, Van Houten DR, Holloszy JO. Insulin action and secretion in endurance-trained and untrained humans. J Appl Physiol (1985). 1987 Dec;63(6):2247-52. doi: 10.1152/jappl.1987.63.6.2247.
PubMed 3325486Mikines KJ, Sonne B, Tronier B, Galbo H. Effects of training and detraining on dose-response relationship between glucose and insulin secretion. Am J Physiol. 1989 May;256(5 Pt 1):E588-96. doi: 10.1152/ajpendo.1989.256.5.E588.
PubMed 2655469Dupre J, Ross SA, Watson D, Brown JC. Stimulation of insulin secretion by gastric inhibitory polypeptide in man. J Clin Endocrinol Metab. 1973 Nov;37(5):826-8. doi: 10.1210/jcem-37-5-826. No abstract available.
PubMed 4749457Holst JJ, Orskov C, Nielsen OV, Schwartz TW. Truncated glucagon-like peptide I, an insulin-releasing hormone from the distal gut. FEBS Lett. 1987 Jan 26;211(2):169-74. doi: 10.1016/0014-5793(87)81430-8.
PubMed 3542566Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993 Jan;91(1):301-7. doi: 10.1172/JCI116186.
PubMed 8423228Knop FK, Aaboe K, Vilsboll T, Volund A, Holst JJ, Krarup T, Madsbad S. Impaired incretin effect and fasting hyperglucagonaemia characterizing type 2 diabetic subjects are early signs of dysmetabolism in obesity. Diabetes Obes Metab. 2012 Jun;14(6):500-10. doi: 10.1111/j.1463-1326.2011.01549.x. Epub 2012 Jan 17.
PubMed 22171657
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Physical Training Effect the Incretin Effect
- ClinicalTrials.gov ID
- NCT01698502
- Acronym / sponsor ID
- EXINT2 / EXINT2_FD
- Conditions
- Healthy
- Keywords
- Incretin, Training, Glucagon like peptide, glucose dependent insulinotropic peptide, Gut, Exercise, Insulin, Focus:
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 24 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Danish University Students from University of Copenhagen,
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Any kind of medication or diabetes in the family (parents, siblings),
- Non-caucasian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8271219Dela F, Handberg A, Mikines KJ, Vinten J, Galbo H. GLUT 4 and insulin receptor binding and kinase activity in trained human muscle. J Physiol. 1993 Sep;469:615-24. doi: 10.1113/jphysiol.1993.sp019833.
- Background: PubMed 1476187Dela F, Mikines KJ, von Linstow M, Secher NH, Galbo H. Effect of training on insulin-mediated glucose uptake in human muscle. Am J Physiol. 1992 Dec;263(6):E1134-43. doi: 10.1152/ajpendo.2006.263.6.E1134.
- Background: PubMed 2651385Mikines KJ, Sonne B, Farrell PA, Tronier B, Galbo H. Effect of training on the dose-response relationship for insulin action in men. J Appl Physiol (1985). 1989 Feb;66(2):695-703. doi: 10.1152/jappl.1989.66.2.695.
- Background: PubMed 1987787Dela F, Mikines KJ, Von Linstow M, Galbo H. Effect of training on response to a glucose load adjusted for daily carbohydrate intake. Am J Physiol. 1991 Jan;260(1 Pt 1):E14-20. doi: 10.1152/ajpendo.1991.260.1.E14.
- Background: PubMed 3325486King DS, Dalsky GP, Staten MA, Clutter WE, Van Houten DR, Holloszy JO. Insulin action and secretion in endurance-trained and untrained humans. J Appl Physiol (1985). 1987 Dec;63(6):2247-52. doi: 10.1152/jappl.1987.63.6.2247.
- Background: PubMed 2655469Mikines KJ, Sonne B, Tronier B, Galbo H. Effects of training and detraining on dose-response relationship between glucose and insulin secretion. Am J Physiol. 1989 May;256(5 Pt 1):E588-96. doi: 10.1152/ajpendo.1989.256.5.E588.
- Background: PubMed 4749457Dupre J, Ross SA, Watson D, Brown JC. Stimulation of insulin secretion by gastric inhibitory polypeptide in man. J Clin Endocrinol Metab. 1973 Nov;37(5):826-8. doi: 10.1210/jcem-37-5-826. No abstract available.
- Background: PubMed 3542566Holst JJ, Orskov C, Nielsen OV, Schwartz TW. Truncated glucagon-like peptide I, an insulin-releasing hormone from the distal gut. FEBS Lett. 1987 Jan 26;211(2):169-74. doi: 10.1016/0014-5793(87)81430-8.
- Background: PubMed 8423228Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993 Jan;91(1):301-7. doi: 10.1172/JCI116186.
- Background: PubMed 22171657Knop FK, Aaboe K, Vilsboll T, Volund A, Holst JJ, Krarup T, Madsbad S. Impaired incretin effect and fasting hyperglucagonaemia characterizing type 2 diabetic subjects are early signs of dysmetabolism in obesity. Diabetes Obes Metab. 2012 Jun;14(6):500-10. doi: 10.1111/j.1463-1326.2011.01549.x. Epub 2012 Jan 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Dela, Prof. MD study chair
University of Copenhagen, Dep. of Biomedical Sciences, Center of healthy Ageing, XLAB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698502, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014; AzTrials last refreshed its copy on 26 Oct 2026.