Trial Outcomes & Findings for Physical Training and the Incretin Effect (NCT NCT01698502)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

21 participants

Primary outcome timeframe

Test day 1 and 2 within 7 days.

Results posted on

2014-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	11	10
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physical Training and the Incretin Effect

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trained n=11 Participants Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml\min-1\kg-1\>60), 20-30 year, BMI: 18,5-25kg/m2, males.	Untrained n=10 Participants Healthy, sedentary (Maximal oxygen uptake (VO2max), ml\min-1\kg-1\<50), 20-30 year, BMI: 18,5-25kg/m2, males.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25 years STANDARD_DEVIATION 3 • n=5 Participants	25 years STANDARD_DEVIATION 3 • n=7 Participants	25 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Denmark	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trained n=11 Participants Healthy, Endurance trained (VO2max, ml\min-1\kg-1\>60), 20-30 year, BMI: 18,5-25kg/m2, males.	Untrained n=10 Participants Healthy, sedentary (VO2max, ml\min-1\kg-1\<50), 20-30 year, BMI: 18,5-25kg/m2, males.
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))	72 percentage Standard Error 4	67 percentage Standard Error 3

SECONDARY outcome

Timeframe: Test day 1 and 2 within 7 days.

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

Outcome measures

Outcome measures
Measure	Trained n=11 Participants Healthy, Endurance trained (VO2max, ml\min-1\kg-1\>60), 20-30 year, BMI: 18,5-25kg/m2, males.	Untrained n=10 Participants Healthy, sedentary (VO2max, ml\min-1\kg-1\<50), 20-30 year, BMI: 18,5-25kg/m2, males.
The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP). Post OGTT	3978 pmol/L * 210 min Standard Error 565	3819 pmol/L * 210 min Standard Error 452
The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP). Post IIGI	692 pmol/L * 210 min Standard Error 103	725 pmol/L * 210 min Standard Error 202

Adverse Events

Trained

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untrained

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Lund

University of Copenhagen

Phone: +45 3532 7519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place