Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Florida Atlantic University Advanced Diabetes Treatment Centers |
---|---|
Information provided by: | Florida Atlantic University |
ClinicalTrials.gov Identifier: | NCT00287651 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, With Complications |
Procedure: Effects of Pulsatile IV Insulin on Diabetic Retinopathy Procedure: Effects of Pulsatile IV Insulin on diabetic retinopathy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy |
Estimated Enrollment: | 300 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2010 |
Arms | Assigned Interventions |
---|---|
2: Active Comparator
Patients with diagnosed Diabetic Retinopathy are enrolled as treated with pulsatile intravenous insulin or as a control patient with weekly treatment sessions. Baseline and quarterly fundus photography is performed to measure and monitor progress.
|
Procedure: Effects of Pulsatile IV Insulin on Diabetic Retinopathy
Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.
|
1: Placebo Comparator
Patients diagnosed with Diabetic Retinopathy are enrolled as control patients that do not receive the pulsatile intravenous insulin therapy. Control patients come into the center receive baseline fundus photography and quarterly fundus photography to measure progress and outcomes of diabetic retinopathy and are compared to the patients who receive pulsatile intravenous insulin therapy.
|
Procedure: Effects of Pulsatile IV Insulin on Diabetic Retinopathy
Control Patients are not given pulsatile intravenous insulin therapy during the study
Procedure: Effects of Pulsatile IV Insulin on diabetic retinopathy
Control patients are not given pulsatile intravenous insulin therapy during the study.
|
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Mahowald, BA | 561 314 2540 | paul@amtcusa.com |
Contact: Dawn Villacci, BA | 561 314 2544 | dvillacci@amtcusa.com |
United States, Florida | |
Florida Atlantic University Center for Complex Systems and Brain Sciences | Recruiting |
Boca Raton, Florida, United States, 33431 | |
Contact: Betty Tuller, Ph.D 561-297-2227 tuller@walt.ccs.fau.edu | |
Principal Investigator: Betty Tuller, Ph.D |
Principal Investigator: | Betty Tuller, Ph.D | Florida Atlantic University |
Study ID Numbers: | H06-230, MH42900 and MH01386 |
Study First Received: | February 6, 2006 |
Last Updated: | October 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00287651 |
Health Authority: | United States: Institutional Review Board |
Pulsatile intravenous insulin Oral carbohydrate loading Respiratory Quotients Hypoglycemia |
Metabolic Diseases Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases Hypoglycemia Insulin |
Diabetic Angiopathies Diabetic Retinopathy Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Retinal Diseases Diabetes Complications |
Hypoglycemic Agents Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |