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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
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Left ventricle ejection fraction (%) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Blood insulin levels (μU/ml: micro international unit per milliliter) [ Time Frame: 1 year ]
  2. Left ventricle fractioning shortening (%) [ Time Frame: 1 year ]
  3. E wave (centimeter per second) [ Time Frame: 1 year ]
  4. A wave (centimeter per second) [ Time Frame: 1 year ]
  5. E deceleration time (seconds) [ Time Frame: 1 year ]
  6. E' (centimeters) [ Time Frame: 1 year ]
  7. A' (centimeters) [ Time Frame: 1 year ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus duration of 2 years and over.

Exclusion Criteria:

  • Previous cardiac disease: valvular, Pacing, Arrhythmias, Primary Cardiomyopathy.

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): NCT02962921


Locations
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Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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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

Publications of Results:

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02962921    
Other Study ID Numbers: 1558-RMB-CTIL
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: First we need to learn how to share data
Additional relevant MeSH terms:
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Ventricular Dysfunction
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs