Exercise, Glucose Kinetics, and the Incretin Effect
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by

About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring Exercise, Physical activity, Type 2 diabetes, Obesity, Incretin effect, GLP-1, GIP, Insulin secretion, Glucagon, Beta-cell function, Disposition Index
Eligibility Criteria
Inclusion Criteria:
- age 18-60 years
- BMI 18-35 kg/m2
Exclusion Criteria:
- 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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Resting Trial
Exercise Trial
Arm Description
a 1 hour period of rest immediately prior to OGTT or isoglycemic clamp
a 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp
Outcomes
Primary Outcome Measures
Glucose tolerance
Incretin effect
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01607931
Brief Title
Exercise, Glucose Kinetics, and the Incretin Effect
Official Title
The Effects of Acute Exercise on Glucose Kinetics, Beta-cell Function and the Incretin Effect in Subjects Representative of the Whole Glucose Tolerance Continuum
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Exercise, Physical activity, Type 2 diabetes, Obesity, Incretin effect, GLP-1, GIP, Insulin secretion, Glucagon, Beta-cell function, Disposition Index
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resting Trial
Arm Type
No Intervention
Arm Description
a 1 hour period of rest immediately prior to OGTT or isoglycemic clamp
Arm Title
Exercise Trial
Arm Type
Experimental
Arm Description
a 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
1 hour of cycling at 50% of maximum power output
Primary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise
Title
Incretin effect
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-60 years
BMI 18-35 kg/m2
Exclusion Criteria:
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
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
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Exercise, Glucose Kinetics, and the Incretin Effect
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