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Effects of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes

NCT00539435 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-08-10

No results posted yet for this study

Summary

The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on heart disease in diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic cardiac disease quality of life questionnaire is completed prior to the start of the treatment and monthly thereafter with detailed analysis performed to measure progress and outcomes. A carotid ultrasound and echocardiogram are performed at baseline and every six months to monitor progress.

Conditions

  • Diabetes Mellitus, With Complications

Interventions

PROCEDURE

Intravenous Insulin on cardiac disease in diabetic pts

Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session

Sponsors & Collaborators

  • Advanced Diabetes Treatment Centers

    collaborator OTHER

  • Florida Atlantic University

    lead OTHER

Principal Investigators

  • Betty Tuller, PhD · Florida Atlantic University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539435 on ClinicalTrials.gov