Exercise, Glucose Kinetics, and the Incretin Effect

This study is currently recruiting participants.
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01607931
First received: May 23, 2012
Last updated: December 22, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: January 2012
Estimated Primary Completion Date: December 2013 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607931

Contacts
Contact: Thomas P Solomon, PhD thomas.solomon@inflammation-metabolism.dk
Contact: Sine H Knudsen, MSc sine_haugaard_2@hotmail.com

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Thomas P Solomon, PhD       thomas.solomon@inflammation-metabolism.dk   
Principal Investigator: Thomas P Solomon, PhD         
Sub-Investigator: Sine H Knudsen, MSc         
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

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: December 22, 2012
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014