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

NCT00287651 | Terminated Phase 2 DMC

• 2 other identifiers: H09-06MH42900 and MH01386
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, With Complications

Keywords

Pulsatile intravenous insulin; Oral carbohydrate loading; Respiratory Quotients; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Serial fundus photography

  Stabilization of retinal blood vessel degeneration

Study Arms (2)

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: Pulsatile IV Insulin; Procedure: Effects of Pulsatile IV Insulin on Diabetic Retinopathy

1

NO INTERVENTION

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.

Interventions

Pulsatile IV Insulin PROCEDURE

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.

2

Effects of Pulsatile IV Insulin on Diabetic Retinopathy PROCEDURE

Control Patients are not given pulsatile intravenous insulin therapy during the study.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Florida Atlantic University: lead
• Advanced Diabetes Treatment Centers: collaborator
• Global Infusions: collaborator

Study Sites (1)

Florida Atlantic University Center for Complex Systems and Brain Sciences

Boca Raton, Florida, 33431, United States

Location

Related Publications (6)

• Frank RN. Diabetic retinopathy. N Engl J Med. 2004 Jan 1;350(1):48-58. doi: 10.1056/NEJMra021678. No abstract available.

  PMID: 14702427 BACKGROUND

• 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. doi: 10.1002/dmrr.415.

  PMID: 14648803 BACKGROUND

• Singleton JR, Smith AG, Russell JW, Feldman EL. Microvascular complications of impaired glucose tolerance. Diabetes. 2003 Dec;52(12):2867-73. doi: 10.2337/diabetes.52.12.2867.

  PMID: 14633845 BACKGROUND

• 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. doi: 10.2165/00129784-200303050-00004.

  PMID: 14728067 BACKGROUND

• Jain A, Sarraf D, Fong D. Preventing diabetic retinopathy through control of systemic factors. Curr Opin Ophthalmol. 2003 Dec;14(6):389-94. doi: 10.1097/00055735-200312000-00012.

  PMID: 14615645 BACKGROUND

• 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. doi: 10.2337/diacare.26.2007.s99. No abstract available.

  PMID: 12502630 BACKGROUND

MeSH Terms

Conditions

Diabetes Complications; Hypoglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Betty Tuller, Ph.D

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: November 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)