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Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03682250
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief Summary:
The population of type 1 diabetes patients with cardiovascular disease is increasing and this study aims to explore the electrocardiographic changes that are associated with spontaneous hypoglycemia in this type of population. More precisely, this study will investigate if these modifications are of the same nature as those already observed in different populations (patients with type 2 diabetes) to see the pro-arrhythmogenic impact of hypoglycemia in patients with type 1 diabetes.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: FreeStyle Libre Pro Device: Holter monitor

Study Type : Observational
Estimated Enrollment : 59 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients With Type 1 Diabetes at High Cardiovascular Risk
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Patients with type 1 diabetes with a high cardiovascular risk Device: FreeStyle Libre Pro
A FreeStyle Libre Pro will be used to identify hypoglycemic episodes

Device: Holter monitor
A Holter monitor will be used to measure heart's activity




Primary Outcome Measures :
  1. QT intervals corrected for heart rate [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Percentage of time between 4.0 and 10.0 mmol/L [ Time Frame: 48 hours ]
  2. Percentage of time below 3.5 mmol/L [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with type 1 diabetes presenting a high cardiovascular risk
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years old;
  • Be able to give informed consent;
  • Diagnosis of type 1 diabetes for ≥ 6 months;
  • Treated with intensive insulin therapy (multiple injections of insulin or insulin pump)

AND EITHER

  • A history of CV disease defined as: 1) Established diagnosis of atherosclerotic coronary artery disease (example: previous history of infarction); 2) Previous cerebral Vascular Stroke or Transient Ischemic Accident; 3) Anterior revascularization of the coronary arteries, carotid artery or peripheral arteries; 4) At least one coronary stenosis, carotid artery or lower extremity arteries > 50%; 5) History of symptomatic coronary heart disease confirmed with hospitalization or a positive stress test result or by any cardiac imaging result, or unstable angina with changes observed at the ECG; 6) Asymptomatic cardiac ischemia confirmed by a nuclear imaging test, an exercise test, a dobutamine stress echo; 7) NYHA II-III class chronic heart failure; 8) Amputation of limb or foot due to circulatory insufficiency.
  • Or more than 30 years duration of T1D and at least 2 of the following risk factors or associated condition: 1) Chronic renal failure eGFR <60 ml / min / 1.73 m2); 2) Presence of micro or macro-albuminuria (albumin / creatinine ratio > 2); 3) Hypertension or treatment for hypertension; 4) Hyperlipidemia or treatment for hypolipemia; 5) Abdominal obesity (Waist circumference> 94 cm for men and > 80 cm for women); 6) Smoking ; 7) Significant retinopathy (pre-proliferative, proliferating, laser or intravitreous injection); 8) Body mass index > 30 kg /m2; 9) Erectile dysfunction; 10) Left ventricular hypertrophy; 11) Positive family history of early MCAS (H < 55 years old and F < 65 years old)

Exclusion Criteria:

  • Definitive criteria: 1) QRS > 120 ms on the baseline ECG; 2) Presence of atrial fibrillation at inclusion; 3) Current intake of any drug that may prolong QT according to the judgment of the investigator and the update of the list available on www.professionsante.com.
  • Transient criteria (the patient can be included once the anomaly is corrected): 1) Hypokalemia (< 3.5 mmol/L); 2) Hypocalcemia (ionized calcium < 1.10 mmol/L); 3) Hypomagnesemia (< 0.7 mmol/L)

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): NCT03682250


Contacts
Contact: Remi Rabasa-Lhoret 1-514-987-5666 remi.rabasa-lhoret@ircm.qc.ca
Contact: Helene Mansaray 1-514-987-5500 ext 3227 mansarayh@yahoo.fr

Locations
Canada, Quebec
Institut de recherches cliniques de Montréal Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Remi Rabasa-Lhoret         
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
Principal Investigator: Remi Rabasa-Lhoret Institut de recherches cliniques de Montréal

Responsible Party: Rémi Rabasa-Lhoret, Full professor, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03682250     History of Changes
Other Study ID Numbers: FRYPOT
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs