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NCT02962921

Acute Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus

Completed Phase 4 Last updated 9 November 2016
What this trial tests

Phase 4 trial testing Insulin LISPRO intravenous loading in Diabetes Mellitus in 6 participants. Completed in 1 November 2004.

Timeline
1 February 2003
Primary endpoint
1 May 2003
1 November 2004

Quick facts

Lead sponsorRambam Health Care Campus
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date1 February 2003
Primary completion1 May 2003
Estimated completion1 November 2004
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rambam Health Care Campus — full company profile →

Who can join

Adults 30 to 65, male only, with Diabetes Mellitus or Ventricular Dysfunction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Acute Effects of Insulin on Cardiac Function in Patients with Diabetes Mellitus: Clinical Applicability and Feasibility.
    Daoud Naccache D, Yalonetsky S, Bar-Yoseph R. · · 2020 · cited 1× · PMID 32308680 · DOI 10.1155/2020/8134548

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Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

Other Rambam Health Care Campus trials

Trials by the same sponsor.

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Data sources for this page

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