Acute Exercise and Pancreatic Endocrine Function
January 30, 2014 updated by: Thomas Solomon, Rigshospitalet, Denmark
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark
- Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: Resting Trial
Pancreatic endocrine function will be determined the morning following a day where no exercise is performed
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pancreatic endocrine function
Time Frame: 24-hours following a period of rest/exercise
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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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24-hours following a period of rest/exercise
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
March 14, 2013
First Submitted That Met QC Criteria
March 14, 2013
First Posted (ESTIMATE)
March 18, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 31, 2014
Last Update Submitted That Met QC Criteria
January 30, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Ex-Panc
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.