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Glucotoxicity and Acute Exercise

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ClinicalTrials.gov Identifier: NCT01771614
Recruitment Status : Withdrawn (PI relocated to a different country.)
First Posted : January 18, 2013
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Behavioral: Exercise Procedure: Hyperglycemia Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Hyperglycaemia on the Response to Acute Exercise
Estimated Study Start Date : August 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771614


Locations
United Kingdom
University of Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TT
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Thomas P Solomon, PhD University of Birmingham

Responsible Party: Thomas Solomon, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01771614     History of Changes
Other Study ID Numbers: GlucotoxEx
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by Thomas Solomon, Rigshospitalet, Denmark:
Glucotoxicity
Exercise
Beta-cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases