Glucotoxicity and Acute Exercise

May 15, 2018 updated by: Thomas Solomon, Rigshospitalet, Denmark

The Effects of Hyperglycaemia on the Response to Acute Exercise

Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
        • University of Birmingham

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria for participation:

  • Male
  • Age 18-50 years
  • Body Mass Index 19-30 kg/m2
  • Generally healthy

Exclusion criteria for participation:

  • Regular use of anti-inflammatory medication
  • Smokers
  • More than 2 kg weight change in prior 6 months
  • Previous weight loss surgery
  • Cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease
  • Evidence of diabetes
  • Engaged in moderate or vigorous activity on more than 5 days per week

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normoglycemia + exercise
At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs.
Behavioral: Exercise
Experimental: Steady-State Hyperglycemia + exercise
At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, steady-state hyperglycemia (~10 mM) will be induced experimentally via a variable-rate intravenous infusion of 20% dextrose. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs.
Behavioral: Exercise
Procedure: Hyperglycemia
Experimental: Fluctuating Hyperglycemia + exercise
At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, fluctuating hyperglycemia (~8-15 mM) will be induced by intravenously injecting 0.15 g/kg boluses of 20% dextrose every 30 minutes. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs.
Behavioral: Exercise
Procedure: Hyperglycemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic endocrine function
Time Frame: 0, 6, 7, 9, and 24 hours
The plasma insulin, C-peptide, and glucagon responses to a 0.33 g/kg intravenous glucose tolerance test (IVGTT) will be measured. In each trial, the IVGTT will be performed at T = 0, 6, 7, 9, and 24 hours.
0, 6, 7, 9, and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance
Time Frame: 0, 6, 7, 9, and 24 hours
Glucose tolerance will be measured during an IVGTT in each trial at T = 0, 6, 7, 9, and 24 hours.
0, 6, 7, 9, and 24 hours
Endothelial function
Time Frame: 0, 6, 7, 9, and 24 hours
Blood flow and flow-mediated dilation by Doppler ultrasound will be measured in each trial at T = 0, 6, 7, 9, and 24 hours.
0, 6, 7, 9, and 24 hours
Oxidative stress
Time Frame: 24 hours
Urine will be collected over the whole 24-hour period of each trial and 8-iso Prostaglandin F3α will be measured.
24 hours

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Thomas P Solomon, PhD, University of Birmingham

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 (Anticipated)

August 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlucotoxEx

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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