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NCT03877406 Clinical Trial

Effect of Empagliflozin on Body Composition and Ketones

Diabetes Mellitus Clinical Trial

Official title:
Decrease in Body Fat and Increase in Ketone Body After 6-month Treatment of Empagliflozin in Korean Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03877406
Other study ID # B-1507/307-007
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 1, 2018
Est. completion date December 31, 2023

Study information
Verified date August 2023
Source Seoul National University Bundang Hospital
Contact Yujin N Shin, MD
Phone 82-31-787-7035
Email 54256@snubh.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Empagliflozin 10 MG
addition of empagliflozin 10 MG
• Hypoglycemics Oral
dose escalation of hypoglycemics oral

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c glycemic control 6 months
Secondary Biochemical parameters Ketone body concentration 6 months
Secondary Body weight Weight change 6 months
Secondary Body fat fat change 6 months
Secondary Systolic and diastolic blood pressures blood pressure change 6 months
Secondary Lipid profile Triglyceride 6 months
Secondary Insulin resistance HOMA-IR 6 months
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