Exercise, Glucose Kinetics, and the Incretin Effect

August 11, 2016 updated by: Thomas Solomon, Rigshospitalet, Denmark

The Effects of Acute Exercise on Glucose Kinetics, Beta-cell Function and the Incretin Effect in Subjects Representative of the Whole Glucose Tolerance Continuum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFSD-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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