Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1Control | No Intervention | Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily | |
| Treatment | Experimental | Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIIIT | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of loss of creatinine clearance | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | 12 to 18 months | |
| Change in cardiac autonomic function | 12 to18 months | |
| Change in retinal photos |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John A D'Elia, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11092517 | Background | Dailey GE, Boden GH, Creech RH, Johnson DG, Gleason RE, Kennedy FP, Weinrauch LA, Weir M, D'Elia JA. Effects of pulsatile intravenous insulin therapy on the progression of diabetic nephropathy. Metabolism. 2000 Nov;49(11):1491-5. doi: 10.1053/meta.2000.17700. | |
| 20189608 | Derived | Weinrauch LA, Sun J, Gleason RE, Boden GH, Creech RH, Dailey G, Kennedy FP, Weir MR, D'Elia JA. Pulsatile intermittent intravenous insulin therapy for attenuation of retinopathy and nephropathy in type 1 diabetes mellitus. Metabolism. 2010 Oct;59(10):1429-34. doi: 10.1016/j.metabol.2010.01.004. Epub 2010 Mar 1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003930 | Diabetic Retinopathy |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 to 18 months |
| Change in cardiac function | 12 to 18 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |