Trial Outcomes & Findings for Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging (NCT NCT02833415)

NCT ID: NCT02833415

Last Updated: 2020-01-23

Results Overview

\[U-13C3\] glycerol enrichment in plasma blood glucose over time will be measured by nuclear magnetic resonance spectroscopy. This is a percentage change from baseline to follow up in the percent enrichment of exogenous glycerol in blood glucose. We are unable to report a measure of central tendency and dispersion as the outcome is a percent change in the area under the enrichment curve for each group between baseline and follow-up. There is no measure of central tendency for these measurements without bootstrapping, which was not performed.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-01-23

Participant Flow

Participant milestones

Measure	Empagliflozin Empagliflozin 10 mg by mouth daily for 3 months. \[U-13C3\] glycerol: Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight). Empagliflozin: Active drug	Placebo Placebo one tablet daily for 3 months \[U-13C3\] glycerol: Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight). Placebo (for Empagliflozin): Placebo tablet manufactured to mimic EMPA 10 mg tablet.
Overall Study STARTED	20	20
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging

Baseline characteristics by cohort

Measure	Empagliflozin n=18 Participants Empagliflozin 10 mg by mouth daily for 3 months. \[U-13C3\] glycerol: Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight). Empagliflozin: Active drug	Placebo n=17 Participants Placebo one tablet daily for 3 months \[U-13C3\] glycerol: Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight). Placebo (for Empagliflozin): Placebo tablet manufactured to mimic EMPA 10 mg tablet.	Total n=35 Participants Total of all reporting groups
Age, Continuous	50.5 years n=5 Participants	54 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized African-American	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Systolic Blood Pressure	126 mmHg n=5 Participants	132 mmHg n=7 Participants	130 mmHg n=5 Participants
Hemoglobin A1C	5.6 percent of glycosylated hemoglobin n=5 Participants	5.9 percent of glycosylated hemoglobin n=7 Participants	5.8 percent of glycosylated hemoglobin n=5 Participants
Body Mass Index	36.8 kg/m^2 n=5 Participants	35.3 kg/m^2 n=7 Participants	35.5 kg/m^2 n=5 Participants
Visceral Fat	5.4 kg n=5 Participants	4.3 kg n=7 Participants	5.4 kg n=5 Participants

PRIMARY outcome

Timeframe: 3 months

[U-13C3] glycerol enrichment in plasma blood glucose over time will be measured by nuclear magnetic resonance spectroscopy. This is a percentage change from baseline to follow up in the percent enrichment of exogenous glycerol in blood glucose. We are unable to report a measure of central tendency and dispersion as the outcome is a percent change in the area under the enrichment curve for each group between baseline and follow-up. There is no measure of central tendency for these measurements without bootstrapping, which was not performed.

Outcome measures

Measure	Empagliflozin n=18 Participants Empagliflozin 10 mg by mouth daily for 3 months. \[U-13C3\] glycerol: Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight). Empagliflozin: Active drug	Placebo n=17 Participants Placebo one tablet daily for 3 months \[U-13C3\] glycerol: Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight). Placebo (for Empagliflozin): Placebo tablet manufactured to mimic EMPA 10 mg tablet.
Change in Glycerol Enrichment	6.5 Percentage change	1.4 Percentage change

Adverse Events

Empagliflozin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Empagliflozin n=20 participants at risk Empagliflozin 10 mg daily by mouth	Placebo n=20 participants at risk Placebo daily by mouth
Renal and urinary disorders Urinary Tract Infection	5.0% 1/20 • Number of events 1 • 3 months Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/20 • 3 months Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

Ian J. Neeland MD

University of Texas Southwestern Medical Center

Phone: 214-645-1267

Email: ian.neeland@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place