Diabetic Nephropathy, Diabetic Retinopathy
Conditions
Keywords
Diabetic autonomic neuropathy
Brief summary
Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).
Interventions
DRUGCIIIT
The intravenous infusion group received three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to subcutaneous insulin.
Sponsors
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function
Exclusion criteria
* Associated active medical diseases that would not permit evaluation of stable renal disease over 18 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of loss of creatinine clearance | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life assessment | 12 to 18 months |
| Change in cardiac autonomic function | 12 to18 months |
| Change in retinal photos | 12 to 18 months |
| Change in cardiac function | 12 to 18 months |
Countries
United States
Outcome results
None listed