Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT02962921|
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Our investigation studies the role of acute insulin administration on the diabetic heart, its corresponding effective blood-insulin level and the time-course applicability of insulin in a routine clinical setting.
A case series of six male (48.1 ± 4.9 y/o) patients with controlled diabetes (HbA1c of 6.6 ± 0.3%, disease duration of 14.4 ± 6.7 yr). Each subject was evaluated for glucose homeostatic, hemodynamic and echocardiographic systolic and diastolic parameters at baseline and following two successive insulin-load steps of a euglycemic hyperinsulinemic clamp study, each 2 h in duration. Results are presented as a mean ± SEM and analysed using the student's t-test.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Ventricular Dysfunction||Drug: Insulin LISPRO intravenous loading||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||November 2004|
Experimental: Diabetic patients
Diabetic patients were treated with insulin loads, left ventricle functional parameters were compared to those of healthy persons.
Metabolic indices of insulin effect: blood insulin levels, glucose disposal rates under insulin infusion, were compared to respective group of healthy persons, studied earlier at our institution Insulin LISPRO intravenous loading
Drug: Insulin LISPRO intravenous loading
intravenous infusion of insulin Lispro.
Other Name: Humalog Insulin
- Left ventricle ejection fraction (%) [ Time Frame: 1 year ]
- Time needed to exert insulin effect on myocardial function (hour) [ Time Frame: 1 year ]Describe the shortest time required for insulin to change myocardial function.
- Blood insulin levels (μU/ml: micro international unit per milliliter) [ Time Frame: 1 year ]
- Left ventricle fractioning shortening (%) [ Time Frame: 1 year ]
- E wave (centimeter per second) [ Time Frame: 1 year ]
- A wave (centimeter per second) [ Time Frame: 1 year ]
- E deceleration time (seconds) [ Time Frame: 1 year ]
- E' (centimeters) [ Time Frame: 1 year ]
- A' (centimeters) [ Time Frame: 1 year ]
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): NCT02962921
|Rambam Medical Center|
|Study Chair:||Eddy Karnieli, MD||Professor emeritus, Faculty of medicine, Technion. Haifa, Israel|
|Principal Investigator:||Ronen Bar Yoseph, MD||Pediatric Pulmonary Institute|
|Principal Investigator:||Sergey Yalonetsky, MD||Cardiology Division|