Exercise, Glucose Kinetics, and the Incretin Effect

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 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 2, 2014

Last verified: December 2014

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: 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: Diabetes Diabetes Medicines Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	December 2015 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Thomas P Solomon, PhD		thomas.solomon@sund.ku.dk

Locations


Denmark
Rigshospitalet	Recruiting
Copenhagen, Denmark
Contact: Thomas P Solomon, PhD thomas.solomon@sund.ku.dk
Principal Investigator: Thomas P Solomon, PhD

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 2, 2014
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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases	Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015

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