Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients with Type 1 Diabetes At High Cardiovascular Risk

Institut de Recherches Cliniques de Montreal1 site in 1 country29 target enrollmentSeptember 17, 2018

ConditionsType 1 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Institut de Recherches Cliniques de Montreal
Enrollment: 29
Locations: 1
Primary Endpoint: QT intervals corrected for heart rate
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 17, 2018

End Date

April 5, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Institut de Recherches Cliniques de Montreal

Responsible Party

Principal Investigator

Rémi Rabasa-Lhoret

Full professor

Institut de Recherches Cliniques de Montreal

Eligibility 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)
•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 20 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)