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PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant period

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516272-14-00
Acronym
N/2015/70
Enrollment
186
Registered
2024-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal transplant

Brief summary

the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)

Detailed description

The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation, The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,, The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,, The cost of the care and treatment up to one year after transplantation.

Interventions

Sponsors

Centre Hospitalier Regional Universitaire
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)

Secondary

MeasureTime frame
The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation, The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,, The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,, The cost of the care and treatment up to one year after transplantation.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026