Clincosm LogoSign in Get a demo

Glucotoxicity and Acute Exercise

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01771614
Collaborator
(none)
0
Enrollment
1
Location
3
Arms
5
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Exercise
  • Procedure: Hyperglycemia
 N/A

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jan 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pancreatic endocrine function [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 [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 [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 [24 hours]

    Urine will be collected over the whole 24-hour period of each trial and 8-iso Prostaglandin F3α will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Solomon, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01771614
Other Study ID Numbers:
  • GlucotoxEx
First Posted:
Jan 18, 2013
Last Update Posted:
May 16, 2018
Last Verified:
May 1, 2018
Keywords provided by Thomas Solomon, Associate Professor, Rigshospitalet, Denmark
Glucotoxicity
Exercise
Beta-cell function
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of May 16, 2018