Acute Exercise and Glucotoxicity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01771614
First received: January 16, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The effects of exercise on glucotoxicity will be determined in healthy subjects. Experimental hyperglycemia will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemic variability. The outcomes of hyperglycemia will be determined by measuring pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Behavioral: Exercise
Procedure: Hyperglycemia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pancreatic endocrine function [ Time Frame: 0, 8, and 24 hours ] [ Designated as safety issue: No ]
    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 0, 8 and 24 hours.


Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 0, 8, and 24 hours ] [ Designated as safety issue: No ]
    Insulin sensitivity will be measured during an IVGTT in each trial at 0, 8, and 24 hours.

  • Endothelial function [ Time Frame: 0, 2, 4, 6, 8, and 24 hours ] [ Designated as safety issue: No ]
    Blood flow and flow-mediated dilation by Doppler ultrasound will be measured in each trial at 0, 2, 4, 6, 8, and 24 hours

  • Oxidative stress [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Urine will be collected over the whole 24-hour period of each trial and 8-iso Prostaglandin F3α will be measured.


Estimated Enrollment: 16
Study Start Date: April 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rest + Steady-State Hyperglycemia
A T = -1 hours, a 1-hour period of rest will begin. At T = 0 h, an 8-hour period of hyperglycemia will begin. Steady-state hyperglycemia will be induced via a constant infusion rate of glucose.
Procedure: Hyperglycemia
Experimental: Rest + Fluctuating Hyperglycemia
A T = -1 hours, a 1-hour period of rest will begin. At T = 0 h, an 8-hour period of hyperglycemia will begin. Fluctuating hyperglycemia will be induced via a variable infusion rate of glucose.
Procedure: Hyperglycemia
Experimental: Exercise + Steady-State Hyperglycemia
A T = -1 hours, a 1-hour exercise bout will begin. At T = 0 h, an 8-hour period of hyperglycemia will begin. Steady-state hyperglycemia will be induced via a constant infusion rate of glucose.
Behavioral: Exercise Procedure: Hyperglycemia
Experimental: Exercise + Fluctuating Hyperglycemia
A T = -1 hours, a 1-hour exercise bout will begin. At T = 0 h, an 8-hour period of hyperglycemia will begin. Fluctuating hyperglycemia will be induced via a variable infusion rate of glucose.
Behavioral: Exercise Procedure: Hyperglycemia

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-60 years old
  • BMI 20-35 kg/m2
  • Willingness to partake in an exercise bout

Exclusion Criteria:

  • Contraindication to strenuous exercise
  • Clinical signs of chronic pulmonary, renal, hepatic, hematological, intestinal, or cardiovascular disease
  • Pregnancy
  • Smoking
  • Recent weight loss (>2kg in 6 months)
  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: NCT01771614

Contacts
Contact: Thomas P Solomon, PhD +4535457629 thomas.solomon@inflammation-metabolism.dk

Locations
Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Capital Region, Denmark, 2100
Contact: Thomas P Solomon, PhD    +4535457629    thomas.solomon@inflammation-metabolism.dk   
Principal Investigator: Thomas P Solomon, PhD         
Sub-Investigator: Kristian Karstoft, MD         
Sub-Investigator: Sine H Knudsen, MSc         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Thomas P Solomon, PhD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Thomas Solomon, Senior Researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01771614     History of Changes
Other Study ID Numbers: Glucotox-2
Study First Received: January 16, 2013
Last Updated: January 16, 2013
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014