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
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: 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 July 28, 2014