Kidney transplant, diabetes. Diabetes mellitus due to underlying condition with diabetic nephropathy
Conditions
Interventions
Intervention 1: Intervention group: 43 patients in the intervention group will receive melatonin (manufactured by Razak Pharmaceutical Company) at a dose of 6 mg daily at night before bed. Each patien
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Individuals who are willing to sign an informed consent form to participate in the study. 2. Age 18 years and older 3. Patient who has undergone a kidney transplant and at least six months have passed since the transplant 4. Agree not to participate in another research study before the study is completed
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical study is not in the patient's best interest based on the decision of the treating physician or the occurrence of events that do not allow the clinical protocol of the study to be carried out completely and safely. 2. Patients with active infection 3. Patients with malignancy 4. Patients who work night shifts 5. Patients who have routinely taken melatonin or antioxidant supplements such as vitamin E, C, coenzyme Q10 and selenium in the past three months 6. Pregnant or breastfeeding women 7. Patients who smoke 8. Patients with chronic liver disease (Child B & C) 9. Hospitalization during the study 10. Patients with mood disorders and taking antidepressants and antipsychotics 11. Patients taking anticonvulsants 12. Patients taking warfarin and strong CYP 1A2 inhibitors such as fluvoxamine and abiraterone 13. Hypersensitivity reaction to melatonin or any of the components of the formulation 14. Patients under treatment with insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Malondialdehyde. Timepoint: At the beginning of the study and 3 months later. Method of measurement: By fluorimetric method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fast blood sugar. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Measuring fasting blood sugar with glucose oxidase enzymatic method. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Shadi Ziaie
Shahid Beheshti University of Medical Sciences
Outcome results
None listed