Previously non-diabetic end stage renal disease patients undergoing kidney transplantation.
Conditions
Interventions
Trade Name: Humulin NPH
Product Name: human insulin isophane
Product Code: 656801.9
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ISOPHANE
CAS Number: 53027-39-7
Other descr
Sponsors
Fundació Institut Mar d'investigacions Mediques
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney. 2. Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose =65 years) yes F.1.3.1 Number of subjects for this age range 380
Exclusion criteria
Exclusion criteria: 1. Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart. 2 Patients receiving an organ transplant other than kidney. 3. Patients receiving an unlicensed drug or therapy within one month prior to study entry. 4. Patients with history of hypersensitivity to injectable insulin. 5. Patients with documented HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to assess the effects of early insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.;Secondary Objective: 1. To determine the improvement in overall glycemic control among patients managed with the early initiation of insulin therapy compared to standard of care management in patients experiencing abnormal glucose metabolism. 2. To determine the improvement in ß-cell function among patients assigned to the early initiation of insulin therapy compared to the standard of care management in patients experiencing abnormal glucose metabolism.;Primary end point(s): The incidence of NODAT 12 months after kidney transplantation defined according to American Diabetes Association criteria.;Timepoint(s) of evaluation of this end point: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The incidence of NODAT at 24 months after kidney transplantation. 2. Glycemia profile during the time of insulin therapy in arm A (intervention) comparing that of arm B (control). 3. The glycemia control using A1c levels, overall and among patients with NODAT, through study period 6, 12 and 24 months after kidney transplantation. 4. Incidence of impaired fasting glycemia and impaired glucose tolerance 6, 12 and 24 months after transplantation. 5. Pancreatic beta-cell function at 6, 12 and 24 months after kidney transplantation, measured as insulin secretion during an OGTT in relation to the glucose stimulation (insulinogenic index total and early phase). 6. Fasting insulin resistance (mostly liver) at 6, 12 and 24 months after kidney transplantation, measured by HOMA-R and by QUICKI (insulin sensitivity) from fasting (basal) glucose and insulin concentration. 7. Dynamic insulin sensitivity (mostly muscle and adipose tissues) at 6, 12 and 24 months after kidney transplantation, measured by OGIS and ISIcomp from OGTT data. 8. Renal function at 6, 12 and 24 months after kidney transplantation, measured by serum creatinine. 9 Patient and graft survival 6, 12 and 24 months after kidney transplantation.;Timepoint(s) of evaluation of this end point: Up to 24 months | — |
Countries
Austria, France, Germany, Spain, United States
Contacts
Public ContactAnna Faura
Fundació Institut Mar d'investigacions Mediques
Outcome results
None listed