Effect of Empagliflozin on Body Composition and Ketones

August 10, 2023 updated by: Soo Lim, Seoul National University Bundang Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yujin N Shin, MD
  • Phone Number: 82317877035 82-31-787-7035
  • Email: 54256@snubh.org

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Soo Lim, MD, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor
Drug: Hypoglycemics Oral
dose escalation of hypoglycemics oral
Other Names:
  • Oral antidiabetic medication escalation
Experimental: Study group
addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents
Drug: Empagliflozin 10 MG
addition of empagliflozin 10 MG
Other Names:
  • SGLT2 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
glycemic control
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical parameters
Time Frame: 6 months
Ketone body concentration
6 months
Body weight
Time Frame: 6 months
Weight change
6 months
Body fat
Time Frame: 6 months
fat change
6 months
Systolic and diastolic blood pressures
Time Frame: 6 months
blood pressure change
6 months
Lipid profile
Time Frame: 6 months
Triglyceride
6 months
Insulin resistance
Time Frame: 6 months
HOMA-IR
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Soo N Lim, MD, PHD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1507/307-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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