Exercise, Glucose Kinetics, and the Incretin Effect
The Effects of Acute Exercise on Glucose Kinetics, Beta-cell Function and the Incretin Effect in Subjects Representative of the Whole Glucose Tolerance Continuum
1 other identifier
interventional
12
1 country
1
Brief Summary
Human volunteers will be stratified by oral glucose tolerance status: normal glucose tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4 experimental trials: \[1\] an oral glucose tolerance test (OGTT) combined with infused and ingested stable isotopes of glucose to assess glucose kinetics. \[2\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by the same OGTT combined with stable isotope glucose tracers used in trial 1. \[3\] an isoglycemic clamp to match the plasma glucose profile measured in trial 1. \[4\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by an isoglycemic clamp to match the plasma glucose profile measured in trial 2. Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon secretion, and the incretin effect will be examined. The exercise responses will be compared between the subjects groups of different glucose tolerance status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Jan 2013
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 12, 2016
August 1, 2016
3.2 years
May 23, 2012
August 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glucose tolerance
Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise
Incretin effect
Plasma insulin and C-peptide will be measured at 10 minute intervals during the OGTT (3 hours) and isoglycemic clamp (3 hours) immediately following the period of rest or exercise
Study Arms (2)
Resting Trial
NO INTERVENTIONa 1 hour period of rest immediately prior to OGTT or isoglycemic clamp
Exercise Trial
EXPERIMENTALa 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp
Interventions
Eligibility Criteria
You may qualify if:
- age 18-60 years
- BMI 18-35 kg/m2
You may not qualify if:
- insulin dependency
- pregnancy
- presence or history of chronic cardiovascular, pulmonary, hepatic, renal, or hematological disease, or cancer
- contraindication to physical activity as assessed by ECG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 30, 2012
Study Start
January 1, 2013
Primary Completion
April 1, 2016
Study Completion
July 1, 2016
Last Updated
August 12, 2016
Record last verified: 2016-08