Clinical trial NCT03682250: Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes
Official title: Electrocardiographic Modifications During Spontaneous Hypoglycemic Episodes in Patients with Type 1 Diabetes At High Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with type 1 diabetes presenting a high cardiovascular risk

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.


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)

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 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)

Primary outcomes:
measure: QT intervals corrected for heart rate
timeFrame: 48 hours
Secondary outcomes:
measure: Percentage of time between 4.0 and 10.0 mmol/L
timeFrame: 48 hours
measure: Percentage of time below 3.5 mmol/L
timeFrame: 48 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Remi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: