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Acute Exercise and Pancreatic Endocrine Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01812590
First Posted: March 18, 2013
Last Update Posted: January 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
  Purpose
Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.

Condition Intervention
Type 2 Diabetes Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Thomas Solomon, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pancreatic endocrine function [ Time Frame: 24-hours following a period of rest/exercise ]
    Insulin and glucagon secretory responses to intravenous glucose (hyperglycemic clamp 5.4 mmol/l above basal), glucagon-like peptide-1 (0.5 pmol/kg/min), and arginine (5 g injection) will be determined.


Enrollment: 14
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Resting Trial
Pancreatic endocrine function will be determined the morning following a day where no exercise is performed
Experimental: Exercise Trial
Pancreatic endocrine function will be determined the morning following a day where a 1-hour aerobic exercise is performed at 65% of pre-determined HRmax (maximal heart rate measured during an incremental work-load exercise test to volitional exhaustion)
Behavioral: Exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures
  • Age 30-70 years
  • BMI 20-40 kg/m2

Exclusion Criteria:

  • Treatment with insulin
  • Contraindication to exercise as determined by ECG
  • Pregnancy
  • Active weight loss in the previous 6 months
  • Actively engaged in exercise training programs
  • Evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease
  Contacts and Locations
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): NCT01812590


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Responsible Party: Thomas Solomon, Senior Researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01812590     History of Changes
Other Study ID Numbers: Ex-Panc
First Submitted: March 14, 2013
First Posted: March 18, 2013
Last Update Posted: January 31, 2014
Last Verified: January 2014