Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy in Patients With Types 1 and 2 Diabetes Mellitus
Stopped early · Phase 2/Phase 3
Conditions studied: Diabetes Mellitus, With Complications
In brief
Diabetic Retinopathy is the leading cause of blindness in the world. Previous studies have documented beneficial effects of physiologic administration of pulsatile insulin on a variety of diabetic complications such as nephropathy, hypertension, glycemic control, etc. Similar pathogenetic mechanisms have been postulated for diabetic retinal disease. This study examines the effect of pulsatile insulin on patients with varying stages of diabetic retinal disease.
Key facts
- Study ID
- NCT00287651
- Run by
- Florida Atlantic University
- People needed
- 150
- Starts
- 2005-11-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2016-08-10
Who can join
Age: 18 and older. 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 18 diagnosed with type 1 or type 2 diabetes mellitus.
- All patients must be diagnosed with type 1 or type 2 diabetes.
- Fundus photographs will be examined by an independent retinal specialist and the patients will be stratified into the three groups as outlined above.
- Endocrinologist must assess and approve patient for participation in this study
- Patient must have the ability to swallow without difficulty and 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 breathe into metabolic measurement cart 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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