CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
[U-13C3] glycerol +2 moredrug
Likely dose
[U-13C3] glycerol 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02833415
NCT02833415Phase 4Completed
CompareCT.gov

Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging

University of Texas Southwestern Medical Center·interventional·Posted Jul 14, 2016·Updated Jan 23, 2020

In Brief

A Phase 4 clinical trial evaluating [U-13C3] glycerol, Empagliflozin, and 1 other intervention for Obesity, Visceral. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study is a clinical study to investigate the gluconeogenesis pathway related to visceral adipose tissue (VAT) in obese individuals without type 2 diabetes and the effects of empagliflozin (EMPA) on glucose homeostasis in viscerally-obese individuals using functional studies of glycerol metabolism in hepatic gluconeogenesis using a well-validated nuclear magnetic resonance (NMR) spectroscopy platform.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Visceral
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 14, 2016
Enrollment StartMar 1, 2016
Primary CompletionJan 1, 2018
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.0 years ago

Interventions

[U-13C3] glyceroldrug

Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight).

Empagliflozindrug

Active drug

Placebo (for Empagliflozin)drug

Placebo tablet manufactured to mimic EMPA 10 mg tablet.