Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287651
Status:
TERMINATED
Last Update Posted:
2016-08-10
First Post:
2006-02-06
Brief Title:
Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy in Patients With Types 1 and 2 Diabetes Mellitus
Sponsor:
Florida Atlantic University
Organization:
Florida Atlantic University
Study Overview
Official Title:
Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Diabetic retinopathy is one of the leading causes of blindness in the world Signs of retinopathy are detected in almost 100 of type 1 diabetic patients who have had their disease for at least 20 years and almost 100 of type 2 diabetic patients with the similar duration of disease 1 Histopathologic findings range from microaneurysms and cotton wool spots to more ominous neovascularization The latter process known as proliferative diabetic retinopathy can progress to total blindness if untreated The biochemical mechanisms responsible for PDR have been extensively studied and appear to be multifactorial Associated findings include abnormalities of vasoactive peptides such as vascular endothelial growth factor VEGF pigment epithelium derived factor PEDF and insulin-like growth factor ILF-1 lipids oxidative pathways enzymatic pathways such as protein kinase and carbohydrate metabolism 1-4 Whether these and other factors are interrelated or have a common underlying defect is unknown The common endpoint however is vascular leakage with neovascularization Current therapeutic regimens based on these biochemical abnormalities have to date been unsuccessful in stemming the progression of proliferative diabetic retinopathy Current treatment strategies emphasize glycemic and blood pressure control with laser photocoagulation and vitrectomy for advanced cases 5
Early retinal disease in diabetic patients may take the form of diabetic macular edema DME This is observed in 20 to 25 of both type 1 and type 2 diabetic patients The pathophysiology of DME involves the leakage of plasma from small vessels in the macula Resorption of this fluid followed by hard exudate formation can lead to severe impairment of central vision 6
Anecdotal evidence from ophthalmologic institutions Houston Eye Institute Shands at University of Florida Bascom Palmer Eye Institute suggests that this treatment arrests the progression of retinal disease in patients with proliferative diabetic retinopathy The mechanism of this effect is unknown but may be related to reversal of retinal ischemia or downregulation of vasoactive peptides by restoration of hepatic metabolism
Protocol
This study is designed as a prospective controlled single blinded evaluation of pulsatile insulin in the role of diabetic retinopathy The patients entered into the study will be from two distinct sources First in conjunction with a national eye imaging company patients with known type 1 or type 2 diabetes will be evaluated for retinal disease This evaluation will consist of mydriatic fundus photography in diabetic patients not having had recent ophthalmologic evaluation period greater than 12 months The fundus photographs will be read by an observer under the auspices of the Wilmer Ophthalmologic Institute at Johns Hopkins Hospital Classifications of patients will be evaluated in this study include
I Patients with non high risk proliferative diabetic retinopathy II Patients with severe non proliferative diabetic retinopathy
Patients who are diagnosed as one of these classifications will be offered entrance into the study Study patients will be matched for age sex and disease severity into a treatment and control group All study patients will be evaluated in conjunction with an ophthalmologist This evaluation will include clinical examination and fundus photography Treatment group patients will undergo weekly pulsatile insulin delivery sessions as per protocol above Control group patients will have weekly clinic visits to maximize glycemic and hypertensive control All patients will repeat their fundus photography at three month intervals with ophthalmologic evaluation as above every six months or more often if requested by the ophthalmologist
Early retinal disease in diabetic patients may take the form of diabetic macular edema DME This is observed in 20 to 25 of both type 1 and type 2 diabetic patients The pathophysiology of DME involves the leakage of plasma from small vessels in the macula Resorption of this fluid followed by hard exudate formation can lead to severe impairment of central vision 6
Anecdotal evidence from ophthalmologic institutions Houston Eye Institute Shands at University of Florida Bascom Palmer Eye Institute suggests that this treatment arrests the progression of retinal disease in patients with proliferative diabetic retinopathy The mechanism of this effect is unknown but may be related to reversal of retinal ischemia or downregulation of vasoactive peptides by restoration of hepatic metabolism
Protocol
This study is designed as a prospective controlled single blinded evaluation of pulsatile insulin in the role of diabetic retinopathy The patients entered into the study will be from two distinct sources First in conjunction with a national eye imaging company patients with known type 1 or type 2 diabetes will be evaluated for retinal disease This evaluation will consist of mydriatic fundus photography in diabetic patients not having had recent ophthalmologic evaluation period greater than 12 months The fundus photographs will be read by an observer under the auspices of the Wilmer Ophthalmologic Institute at Johns Hopkins Hospital Classifications of patients will be evaluated in this study include
I Patients with non high risk proliferative diabetic retinopathy II Patients with severe non proliferative diabetic retinopathy
Patients who are diagnosed as one of these classifications will be offered entrance into the study Study patients will be matched for age sex and disease severity into a treatment and control group All study patients will be evaluated in conjunction with an ophthalmologist This evaluation will include clinical examination and fundus photography Treatment group patients will undergo weekly pulsatile insulin delivery sessions as per protocol above Control group patients will have weekly clinic visits to maximize glycemic and hypertensive control All patients will repeat their fundus photography at three month intervals with ophthalmologic evaluation as above every six months or more often if requested by the ophthalmologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MH42900 and MH01386 | None | None | None |