Exercise in Type 1 Diabetes Mellitus

NCT02075567 | Completed DMC

• 1 other identifier: ExT1DM
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Glucose Decrease During and After Defined Individual Exercise in T1DM

Keywords

Diabetes Mellitus Type 1; Exercise; Insulin Reduction; Glucose; Hypoglycemia; Continuous Glucose Monitoring System

Outcome Measures

Primary Outcomes (1)

• Number of Participants with no Adverse Events as a Measure of Safety and Tolerability

  Blood Glucose decrease from baseline during and after constant load and high intensity intermittent cycle ergometer exercise tests before standardized Bolus Insulin regimen

  30min

Secondary Outcomes (1)

• Hormonal Response

  Starting point, middle and End point (30min)

Other Outcomes (1)

• Blood Lactate Concentration

  30min

Study Arms (1)

Therapy adaption T1DM

EXPERIMENTAL

Procedure: Experimental

Interventions

Experimental PROCEDURE

Therapy adaption T1DM

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• University of Graz: collaborator

Related Publications (4)

• McCarthy O, Pitt J, Wellman B, Eckstein ML, Moser O, Bain SC, Bracken RM. Blood Glucose Responses during Cardiopulmonary Incremental Exercise Testing in Type 1 Diabetes: A Pooled Analysis. Med Sci Sports Exerc. 2021 Jun 1;53(6):1142-1150. doi: 10.1249/MSS.0000000000002584.

  PMID: 33315813 DERIVED

• Moser O, Tschakert G, Mueller A, Groeschl W, Eckstein ML, Koehler G, Bracken RM, Pieber TR, Hofmann P. Different Heart Rate Patterns During Cardio-Pulmonary Exercise (CPX) Testing in Individuals With Type 1 Diabetes. Front Endocrinol (Lausanne). 2018 Oct 2;9:585. doi: 10.3389/fendo.2018.00585. eCollection 2018.

  PMID: 30333794 DERIVED

• Moser O, Tschakert G, Mueller A, Groeschl W, Pieber TR, Koehler G, Eckstein ML, Bracken RM, Hofmann P. Atypical blood glucose response to continuous and interval exercise in a person with type 1 diabetes: a case report. J Med Case Rep. 2017 Jun 30;11(1):176. doi: 10.1186/s13256-017-1355-7.

  PMID: 28662684 DERIVED

• Moser O, Tschakert G, Mueller A, Groeschl W, Pieber TR, Obermayer-Pietsch B, Koehler G, Hofmann P. Effects of High-Intensity Interval Exercise versus Moderate Continuous Exercise on Glucose Homeostasis and Hormone Response in Patients with Type 1 Diabetes Mellitus Using Novel Ultra-Long-Acting Insulin. PLoS One. 2015 Aug 28;10(8):e0136489. doi: 10.1371/journal.pone.0136489. eCollection 2015.

  PMID: 26317981 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Thomas R. Pieber, Prof. Dr.

  Medical University of Graz, Division of Endocrinology and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03