Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise in Type 1 Diabetes Mellitus (ExT1DM)

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.
 
ClinicalTrials.gov Identifier: NCT02075567
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
University of Graz
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz

Brief Summary:

Background: During and after exercise there is a twofold stimulation of glucose transporter type 4 in type 1 diabetes mellitus (T1DM) caused by an exogenous insulin injection and muscle contraction. In case of no insulin reduction before exercise and/or an additional carbohydrate supplement patients with T1DM would become hypoglycemic. There are no specific data dependent on individual exercise intensities and strategies of bolus insulin reduction. The aim of the present study is to avoid hypoglycemia during and after exercise and to calculate a critical time where blood glucose would decrease to 50% of baseline by a pre exercise standardized insulin regimen during standardized cycle ergometer exercises dependent on different modes, intensities and energy expenditures as well as counter regulatory hormones.

Methods/design: Participants consist of 7 male subjects aged 18 to 35 years with T1DM (fasting C-peptide (≤ 0.3 nmol/l), HbA1c ≤ 64 mmol/mol). After a four-weeks basal insulin adaptation of ultralong-acting basal insulin (Novo Nordisk) each subject will perform a maximal incremental cycle ergometer exercise test with a reduction of short time insulin of 40% to determine the individual aerobic/anaerobic threshold called first/second lactate turn point (LTP1, LTP2). Four constant load and three high intensity intermittent cycle ergometer exercise tests (30min) will be performed at 5% Pmax below and above LTP1 and LTP2 (at 5% above LTP2 no high intensity intermittent cycle ergometer exercise test) with a reduction of short time insulin doses (standardized breakfast-four hours before each test) of 25% at 5% Pmax below LTP1 and 50% at 5% Pmax above LTP1 and 75% at 5% Pmax below and above LTP2 with one week interception between testing. 24h before testing subjects will be fitted with a continuous glucose monitoring system for at least 48h. Primary outcomes include blood glucose decrease from baseline during constant load tests, energy expenditure during testing, 24h CGMS measurements and hormones catecholamines, cortisol, glucagon and insulin growth factor 1. Secondary outcome measurements include heart rate, lactate and respiratory gas exchange values.

Discussion: If the results confirm the hypothesis, this study could be one of the first recommendations for T1DM patients, how to adapt bolus insulin dose individually before defined exercises without the risk hypoglycemia during and after exercise.


Condition or disease Intervention/treatment Phase
Blood Glucose Decrease During and After Defined Individual Exercise in T1DM Procedure: Experimental Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Exercise and Blood Glucose Levels in Patients With Type I Diabetes - a Pilot Study
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapy adaption T1DM Procedure: Experimental



Primary Outcome Measures :
  1. Number of Participants with no Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 30min ]
    Blood Glucose decrease from baseline during and after constant load and high intensity intermittent cycle ergometer exercise tests before standardized Bolus Insulin regimen


Secondary Outcome Measures :
  1. Hormonal Response [ Time Frame: Starting point, middle and End point (30min) ]
    Difference between constant load and high intensity intermittent cycle ergometer exercise tests to hormones Tri-Cat, Cortisol, Glucagon and Insulin-like Growth factor (IGF-1)


Other Outcome Measures:
  1. Blood Lactate Concentration [ Time Frame: 30min ]
    Increased Blood Lactate Levels induced by high intensity anaerobic exercise selectively inhibit glycolysis and cellular Glucose uptake.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must give their signed and dated informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
  • Male subjects with T1DM with duration ≥12 month
  • Age ≥ 18 to ≤ 35 years, both inclusive
  • HbA1c ≤ 64 mmol/mol
  • Fasting C-peptide ≤ 0.3 nmol/l
  • Treatment with intensified insulin therapy or insulin pump therapy
  • No diabetic long term complications
  • No other physical and/or mental disease

Exclusion Criteria:

  • Previous participation in this trial
  • History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial
  • Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia
  • Current addiction to alcohol or substances of abuse as determined by the investigator
  • Known or suspected allergy to trial products or related products
  • Any condition that the investigator feels would interfere with the trial participation or evaluation of data

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): NCT02075567


Sponsors and Collaborators
Medical University of Graz
University of Graz
Investigators
Layout table for investigator information
Principal Investigator: Thomas R. Pieber, Prof. Dr. Medical University of Graz, Division of Endocrinology and Metabolism

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pieber Thomas, MD, Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT02075567     History of Changes
Other Study ID Numbers: ExT1DM
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Pieber Thomas, MD, Medical University of Graz:
Diabetes Mellitus Type 1
Exercise
Insulin Reduction
Glucose
Hypoglycemia
Continuous Glucose Monitoring System