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Acute Exercise and Pancreatic Endocrine Function

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ClinicalTrials.gov Identifier: NCT01812590
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : January 31, 2014
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment
Type 2 Diabetes Behavioral: Exercise

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2013
Primary Completion Date : June 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

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

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

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

Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark

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