Effect of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes

Stopped early · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to determine the effect of Pulsatile Intravenous Insulin therapy on circulating blood markers. These blood markers are selected due to their correlation to and possible pathogenetic roles in vascular compromise and inflammatory malfunction in diabetic patients.

Key facts

Study ID

NCT00361907

Run by

Florida Atlantic University

People needed

105

Starts

2005-02-01

Expected to finish

2009-08-01

Last updated by the study team

2016-08-09

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• We will include up to 500 patients both male and female over the age of 21 diagnosed with type 1 or type 2 diabetes mellitus
• All patients must have secondary complications caused by the diabetes and not responding to conventional medical management
• Under an Endocrinologists supervision for their diabetes management
• Endocrinologist must assess and approve patient for participation in this study
• Ability to swallow without difficulty
• Ability to commit to the weekly time requirements associated with the study

You may not qualify if…

• Other causes of complications not related to diabetes
• Lack of intravenous access
• Pregnancy
• Alcohol abuse, drug addiction or the use of illegal drugs
• Positive HIV
• Inability to perform breathe into machine for respiratory quotients

Where it is running

• Florida Atlantic University Center for Complex Systems and Brain Sciences — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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