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Evaluation of Glycemic Changes During Exercise in Children With Type 1 Diabetes (TREAD-DIAB)

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ClinicalTrials.gov Identifier: NCT02824510
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG evolution without insulin dose modification in patients with T1D under continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare differences between these 2 groups; 2) to evaluate the impact of insulin dose modification (bolus, basal, reduction or increase, based on SG evolution profile obtained after first exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen, and compare differences between these 2 groups.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Algorithmic changes in insulin therapy. Other: Treadmill exercises Drug: Insulin aspart, glargine and detemir Not Applicable

Detailed Description:

Intervention and procedures:

a) The patients will first be assigned to standardized moderate-to-vigorous exercise for SG determination; b) similar exercise will then be repeated with preemptive adaptation of insulin dose (tailored on SG evolution during first exercise) for determination of potential influences on SG evolution.

Intervention Plan:

  • At first visit (day [>18h] before exercise): setting of a Continuous Glucose Monitoring System
  • At second visit: moderate-to-vigorous exercise with treadmill.
  • At third visit (2 days after exercise): removal of CGMS
  • At fourth visit (day [>18h] before fifth visit): setting of a Continuous Glucose Monitoring System
  • At fifth visit: moderate exercise with treadmill, and insulin dose modification (basal rate, bolus, reduction, increase)
  • At sixth visit (2 days after exercise): removal of CGMS
  • Total number of visits: 6
  • The exercises will be performed between 1 and 2 hours after breakfast or after lunch; the second exercise will be performed ≥2 weeks after the first exercise.

Controls:

  • Moderate exercise with and without modification of insulin dose in MDI patients (by comparison with CSII patients). MDI patients will be matched to CSII patients according to gender, age, BMI (±0.5 z-score) and HbA1C levels (±1%) to exclude any bias in patient allocation.
  • Moderate exercise without modification of insulin dose at first visit (by comparison with modification of insulin dose).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Glycemic Changes and Optimization of Glycemic Control During Exercise in Children With Type 1 Diabetes Under Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection Regimen (MDI) (TREAD-DIAB Study)
Study Start Date : August 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patients under insulin pump therapy.
Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
Other: Algorithmic changes in insulin therapy.
Based on SG evolution in first treadmill test, algorithms will evaluate the modifications in insulin therapy required to normalize SG during the second treadmill test.

Other: Treadmill exercises
25 min treadmill exercise at 60% of maximal heart rate estimated for age

Drug: Insulin aspart, glargine and detemir
Active Comparator: Patients under MDI.
Patients under multiple daily injection regimen. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart and glargine or detemir).
Other: Algorithmic changes in insulin therapy.
Based on SG evolution in first treadmill test, algorithms will evaluate the modifications in insulin therapy required to normalize SG during the second treadmill test.

Other: Treadmill exercises
25 min treadmill exercise at 60% of maximal heart rate estimated for age




Primary Outcome Measures :
  1. Subcutaneous glucose evolution [ Time Frame: 12 months ]
    Subcutaneous glucose evolution after completion of 2 exercise tests



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T1D (according to the ISPAD 2011 guidelines)
  • T1D outside of partial remission phase (defined according to the IDAA1C definition [Diabetes Care 2007], being equal to A1C (%) + [4 x insulin dose (units per kilogram per 24 h)] and at least > 2 years after T1D diagnosis (defined as the first day of insulin therapy)

Exclusion Criteria:

  • Non-type 1 diabetes
  • Severe neonatal asphyxia (defined as Apgar score 3 or less after 5 min), children born small for gestational age, chronic systemic disease, active malignancy, hypothyroidism, hypopituitarism, developmental delay, bladder dysfunction, obesity, carnitine deficiency, β-oxidation defect, cardiac malformations, dysrhythmia
  • Intake of drugs interfering with insulin sensitivity (e.g. corticosteroids, GH).
  • HbA1C >9.5% at the time of enrollment in the study.

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): NCT02824510


Locations
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Belgium
Pediatric Endocrinology
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Philippe A Lysy, MD PhD Cliniques Universitaires Saint Luc, Belgium
Publications of Results:
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02824510    
Other Study ID Numbers: 2013/18NOV/510
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs