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Exercise, Glucose Kinetics, and the Incretin Effect

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ClinicalTrials.gov Identifier: NCT01607931
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607931


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016

Keywords provided by Thomas Solomon, 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