Exercise, Glucose Kinetics, and the Incretin Effect

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Thomas Solomon, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01607931

First received: May 23, 2012

Last updated: August 11, 2016

Last verified: August 2016

History of Changes

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Thomas Solomon, 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 ]
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 ]


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

Locations


Denmark
Rigshospitalet
Copenhagen, Denmark

Sponsors and Collaborators

Rigshospitalet, 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

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

ClinicalTrials.gov processed this record on September 25, 2017

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