Acute Exercise and Pancreatic Endocrine Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01812590
First received: March 14, 2013
Last updated: January 30, 2014
Last verified: January 2014
  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: 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: 24-hours following a period of rest/exercise ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812590

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

No publications provided

Responsible Party: Thomas Solomon, Senior Researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01812590     History of Changes
Other Study ID Numbers: Ex-Panc
Study First Received: March 14, 2013
Last Updated: January 30, 2014
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014