Diabetes Mellitus, Type 2
Conditions
Brief summary
Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the daily metformin prescribed dose and the impact of renal function and concomitant medication in diabetic patients over 65 years.
Detailed description
The study was commissioned by the Italian Association of Clinical Endocrinologists (Association of Medical Endocrinologists - AME) and approved by the Ethical Committee of Cuneo Hospital. The research was open to all specialists taking care of patients with diabetes in Italy. The primary endpoint was the evaluation of metformin dosage. Secondary endpoints were the relationship between the metformin dosage and the renal filtration rate and the relationship between the metformin dosage and the concomitant medication. An ad hoc form was developed and used to record all medical findings. The form was emailed to all participating centers who then emailed or faxed it back to the investigator's data manager. Data were checked for accuracy. The following data were required: age, gender, body weight and height, diabetes duration, type of metformin (classical/slow), daily dosage of metformin, reported side effects,concomitant medications. Serum creatinine and HbA1c levels obtained within the previous two months were also required. Each participating center recruited about 50 diabetic outpatients. Inclusion criteria were as follows: adult outpatients ≥ 65 years with T2 diabetes mellitus, using metformin for at least six months, usually assuming three daily meals, and capable of informed consent.
Interventions
None listed
Sponsors
Associazione Medici Endocrinologi
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Inclusion criteria
* adult outpatients (≥65 years); * T2 diabetes mellitus; * Taking metformin for at least six months; * assuming three daily meals; * capable of informed consent.
Exclusion criteria
* severe liver or renal failure (eGFR \<30 mL/min/1.73 m2); * hospitalization for any cause in the last six month; * glucocorticoid treatment in the last six month; * oncologic treatment in the last six month; * Ramadan in the last six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| metformin daily dose in diabetic outpatients type 2 | six months | relationship between metformin dose and filtration rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| renal filtration rate | six months | relationship between metformin rate and concomitant medication |
Countries
Italy
Contacts
Primary ContactBarbara Martello
Backup ContactGiorgio Borretta, MD
Outcome results
None listed