Exercise, Glucose Kinetics, and the Incretin Effect
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | January 2013 |
| Study Completion Date: | July 2016 |
| Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Resting Trial
a 1 hour period of rest immediately prior to OGTT or isoglycemic clamp
|
|
|
Experimental: Exercise Trial
a 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp
|
Behavioral: Exercise
1 hour of cycling at 50% of maximum power output
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01607931
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark | |
More Information
| Responsible Party: | Thomas Solomon, Senior Researcher, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01607931 History of Changes |
| Obsolete Identifiers: | NCT01540097 |
| Other Study ID Numbers: | EFSD-2012 |
| Study First Received: | May 23, 2012 |
| Last Updated: | August 11, 2016 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by Rigshospitalet, Denmark:
|
Exercise Physical activity Type 2 diabetes Obesity Incretin effect GLP-1 |
GIP Insulin secretion Glucagon Beta-cell function Disposition Index |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016