Effect of Empagliflozin on Body Composition and Ketones

Phase 4

Recruiting

• Conditions: Diabetes Mellitus; Fat; Intolerance, Pancreas
• Interventions: Drug: Hypoglycemics Oral; Drug: Empagliflozin 10 MG

• Registration Number: NCT03877406
• Lead Sponsor: Seoul National University Bundang Hospital

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).

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Hypoglycemics Oral	up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor
Study group	Empagliflozin 10 MG	addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months	glycemic control

Secondary Outcome Measures

Name	Time	Method
Body weight	6 months	Weight change
Body fat	6 months	fat change
Lipid profile	6 months	Triglyceride
Insulin resistance	6 months	HOMA-IR
Biochemical parameters	6 months	Ketone body concentration
Systolic and diastolic blood pressures	6 months	blood pressure change

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of