Metformin Use in Chronic Kidney Disease: The CKD-Met Study

Study Overview
=================
Brief Summary
-----------------
Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit. Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients. The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.

Official Title
-----------------
Metformin Use in Chronic Kidney Disease: The CKD-Met Study

Conditions
-----------------
Type 2 Diabetes, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: modalities of metformin prescription


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or more Type 2 diabetes Seen by a nephrologist (consultation or hospitalization) between March 2014 and March 2020 in the Department of Nephrology, Lyon Sud university hospital, France Exclusion Criteria: On-going treatment by dialysis Kidney transplantation Type 1 diabetes Missing data (metformin treatment)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5)<br>All patients with type 2 diabetes seen for the first time by a nephrologist. | Other: modalities of metformin prescription<br>* Metformin prescription or not, in each CKD stage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients receiving metformin | metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded. | every January 1st up to 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of metformin | metformin use during chronic kidney disease. Dose of metformin will be recorded. | every January 1st up to 2020 | 
| Occurence of reasons for non-prescription of metformin | metformin use during chronic kidney disease. Occurence of reasons for non-prescription of metformin will be recorded. | every January 1st up to 2020 | 
| CKD stages | CKD stages will be recorded. | every January 1st up to 2020 | 
| Doses of oral antidiabetes medications | Oral antidiabetic medications use during chronic kidney disease. Doses of oral antidiabetes medications (sulfonylureas, alpha-glucosidase inhibitors, Dipeptidyl peptidase-4 (DPP4) inhibitors, incretin mimetics, SGLT2 inhibitors) will be recorded. | every January 1st up to 2020 | 
| starting time of insulin | need for insulin | every January 1st up to 2020 | 
| occurrence of lactic acidosis | data file analysis and record of lactic acidosis episodes | every January 1st up to 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, type 2 diabetes, chronic kidney disease, antidiabetic medications, lactic acidosis