Diabetes Mellitus, Fat; Intolerance, Pancreas
Conditions
Keywords
Sodium-glucose transporter 2 inhibitor
Brief summary
The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
Detailed description
Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
Interventions
DRUGEmpagliflozin 10 MG
addition of empagliflozin 10 MG
DRUGHypoglycemics Oral
dose escalation of hypoglycemics oral
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45
Exclusion criteria
Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI \< 20 kg/m2 eGFR \< 45 Malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 6 months | Weight change |
| Body fat | 6 months | fat change |
| Biochemical parameters | 6 months | Ketone body concentration |
| Lipid profile | 6 months | Triglyceride |
| Insulin resistance | 6 months | HOMA-IR |
| Systolic and diastolic blood pressures | 6 months | blood pressure change |
Countries
South Korea
Contacts
Primary ContactYujin N Shin, MD
Backup ContactSoo N Lim
Outcome results
None listed