Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy in Patients With Types 1 and 2 Diabetes Mellitus - Full Text View

Sponsors and Collaborators:	Florida Atlantic University Advanced Diabetes Treatment Centers
Information provided by:	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00287651

Purpose

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

MedlinePlus related topics: Diabetes Diabetic Eye Problems Retinal Disorders

Drug Information available for: Insulin

U.S. FDA Resources

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

Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:

Serial fundus photography [ Time Frame: Stabilization of retinal blood vessel degeneration ]
Retinal Specialist Wilmer Eye Institute at Johns Hopkins [ Time Frame: Stabilization of retinal blood vessel degeneration ]

Secondary Outcome Measures:

optical coherent tomography [ Time Frame: Stabilization of retinal blood vessel degeneration ]

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.

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

We will include up to 300 patients both male and female over the age of 21 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287651

Contacts

Contact: Paul Mahowald, BA	561 314 2540	paul@amtcusa.com
Contact: Dawn Villacci, BA	561 314 2544	dvillacci@amtcusa.com

Locations

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

Sponsors and Collaborators

Florida Atlantic University

Advanced Diabetes Treatment Centers

Investigators

Principal Investigator:

Betty Tuller, Ph.D

Florida Atlantic University

More Information

Publications:

Frank RN. Diabetic retinopathy. N Engl J Med. 2004 Jan 1;350(1):48-58. Review. No abstract available.

Caldwell RB, Bartoli M, Behzadian MA, El-Remessy AE, Al-Shabrawey M, Platt DH, Caldwell RW. Vascular endothelial growth factor and diabetic retinopathy: pathophysiological mechanisms and treatment perspectives. Diabetes Metab Res Rev. 2003 Nov-Dec;19(6):442-55. Review.

Singleton JR, Smith AG, Russell JW, Feldman EL. Microvascular complications of impaired glucose tolerance. Diabetes. 2003 Dec;52(12):2867-73. Review.

Misra A, Kumar S, Kishore Vikram N, Kumar A. The role of lipids in the development of diabetic microvascular complications: implications for therapy. Am J Cardiovasc Drugs. 2003;3(5):325-38. Review.

Jain A, Sarraf D, Fong D. Preventing diabetic retinopathy through control of systemic factors. Curr Opin Ophthalmol. 2003 Dec;14(6):389-94.

Fong DS, Aiello L, Gardner TW, King GL, Blankenship G, Cavallerano JD, Ferris FL 3rd, Klein R; American Diabetes Association. Diabetic retinopathy. Diabetes Care. 2003 Jan;26 Suppl 1:S99-S102. No abstract available.

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

Keywords provided by Florida Atlantic University:

Pulsatile intravenous insulin
Oral carbohydrate loading
Respiratory Quotients
Hypoglycemia

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009