Trial Outcomes & Findings for SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot (NCT NCT04907214)

NCT ID: NCT04907214

Last Updated: 2023-12-29

Results Overview

Pro-inflammatory T helper type 1 cells are quantified using flow cytometry

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2023-12-29

Participant Flow

* 17 in the Original study + 21 in the Extension study signed consent for a total of 38. * 9 individuals in the Extension study did not perform screening procedures after consent and were not enrolled. In total 29 individuals enrolled. * 11 individuals in the Original study and 2 individuals in the Extension study did not meet inclusion/exclusion criteria after screening. * 6 individuals in the Original study and 10 individuals in the Extension study started and completed study days.

Participant milestones

Participant milestones
Measure	Empagliflozin Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

-One individual could not tolerate the liposuction and did not provide a sample.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empagliflozin n=6 Participants Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Age, Continuous	51.5 years STANDARD_DEVIATION 16.5 • n=6 Participants
Sex: Female, Male Female	6 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	2 Participants n=6 Participants
Race (NIH/OMB) White	3 Participants n=6 Participants
Race (NIH/OMB) More than one race	1 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Region of Enrollment United States	6 participants n=6 Participants
Pro-inflammatory T helper type 1 cells in adipose tissue	13.0 Percentage of CD3+ T cells STANDARD_DEVIATION 5.2 • n=5 Participants • -One individual could not tolerate the liposuction and did not provide a sample.

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: One individual did not tolerate the liposuction technique and did not provide adipose tissue for the study.

Pro-inflammatory T helper type 1 cells are quantified using flow cytometry

Outcome measures

Outcome measures
Measure	Empagliflozin n=5 Participants Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months	-1.6 Percentage of CD3+ T cells Standard Deviation 1.8

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia.

Outcome measures

Outcome measures
Measure	Empagliflozin n=6 Participants Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Change in Flow-mediated Dilation After 3 Months	-2.33 Percentage change in diameter Standard Deviation 7.72

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP)

Outcome measures

Outcome measures
Measure	Empagliflozin n=6 Participants Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Change in Liver Steatosis at 3 Months	0.17 Decibels per meter Standard Deviation 28.12

SECONDARY outcome

Timeframe: Baseline to 2 weeks

Population: One individual did not tolerate the liposuction technique and did not provide adipose tissue for the study.

Pro-inflammatory T cells are quantified using flow cytometry

Outcome measures

Outcome measures
Measure	Empagliflozin n=5 Participants Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks	-0.5 Percentage of CD3+ T cells Standard Deviation 5.0

SECONDARY outcome

Timeframe: Baseline to 12 weeks

IL-6 is quantified in plasma samples.

Outcome measures

Outcome measures
Measure	Empagliflozin n=6 Participants Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months	0.078 picogram per milliliter Standard Deviation 0.717

Adverse Events

Empagliflozin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Empagliflozin n=6 participants at risk Individuals receive empagliflozin 25mg/day orally for 12 weeks Empagliflozin 25 MG: Oral empagliflozin daily
Skin and subcutaneous tissue disorders Skin infection	16.7% 1/6 • 12 weeks
Nervous system disorders Headache	16.7% 1/6 • Number of events 2 • 12 weeks

Additional Information

Dr. Mona Mashayekhi

Vanderbilt University Medical Center

Phone: 615-936-1760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place