Linagliptin in Post-renal Transplantation

NCT ID: NCT03970668

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-04-30

Brief Summary

Post-renal transplanted patients frequently present hyperglycemia immediately after the procedure.

This was a retrospective comparative study performed in post-renal transplanted patients in a single high speciality center with the goal of compare the effect of linagliptin + insulin in post-renal transplanted patients with hyperglycemia Interventions were linagliptin 5mg daily plus insulin vs insulin alone during 5 days after renal transplantation with hyperglycemia, and the main outcome were glucose levels, insulin dose and severity of hypoglycemia

Detailed Description

This was a retrospective comparative study performed in a single center between 2016 and 2018, included the data collected from 28 hospitalized post-renal transplanted patients that presented hyperglycemia (>140 mg/dl or or 7.77 mmol/l) immediately after renal transplantation (RT); 14 patients were treated with linagliptin 5mg daily plus a basal bolus insulin scheme prescribed by the Endocrinology group at the hospital, and 14 patients treated only with basal bolus insulin scheme were randomly selected from a list of patients treated during the same period of time and by the same Endocrinology group. Linagliptin dose was 5mg daily and the basal bolus insulin regimen was started and adjusted according to the international guidelines; in general, patients received a starting insulin dose of around 0.5 U/kg/day, given half as basal insulin (NPH or Glargine) once or twice daily and half as insulin lispro divided into three equal doses before meals. Insulin dose was adjusted daily to achieve the goal of fasting glucose between 80-140 mg/dl (4.44-7.77 mmol/l) or random glucose levels below 180 mg/dl (9.99 mmol/l). Correctional insulin dose was used before each meal, depending on the glucose measurements, starting at 1 unit for each 40mg above 140 mg/dl (7.77 mmol/l) of glucose. Glucose levels were monitored at fasting and before each meal, as well as at bedtime according to standard clinical practice. Data regarding fasting and preprandial glucose levels, hypoglycemia, renal function, and immunosuppression therapy were recorded from the patient´s file during the first 5 days after RT; fasting glucose and renal function were also recorded at 1, 6 and 12 months after RT. Patients were included if they were between 18-65 years of age and presented fasting hyperglycemia (>140 mg/dl or 7.77 mmol/l) immediately after RT.

Ethical and Research committee (CEI) at the Hospital approved the study protocol with the number CEI-49-18.

Conditions

Transplanted Kidney Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Linagliptin plus insulin

Patients that presented hyperglycemia immediately after renal transplantation and received treatment with linagliptin plus insulin

Linagliptin 5 mg Oral Tablet

Intervention Type: DRUG

Patients received linagliptin 5mg once daily orally plus a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)

Insulin

Patients that presented hyperglycemia immediately after renal transplantation and received treatment only with insulin

Insulin

Intervention Type: DRUG

Patients received a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)

Interventions

Linagliptin 5 mg Oral Tablet

Patients received linagliptin 5mg once daily orally plus a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)

Intervention Type: DRUG

Insulin

Patients received a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)

Intervention Type: DRUG

Other Intervention Names

Linagliptin 5mg once daily plus insulin scheme; Basal bolus insulin scheme

Eligibility Criteria

Inclusion Criteria

• Hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation

Exclusion Criteria

• Incomplete records on the patients file
• Acute complications such as liver failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Regional de Alta Especialidad del Bajio

OTHER

Sponsor Role: collaborator

Universidad de Guanajuato

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Guardado Mendoza

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodolfo Guardado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional de Alta Especialidad del Bajio

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CEI-49-18

Identifier Type: -

Identifier Source: org_study_id