Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging

Conditions

• Obesity, Visceral

Eligibility Criteria

Sex

ALL

Age

30 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• [U-13C3] glycerol — DRUG
  Ingestion of \[U-13C3\] glycerol based on human's body weight such as (50 mg/kg body weight).
• Empagliflozin — DRUG
  Active drug
• Placebo (for Empagliflozin) — DRUG
  Placebo tablet manufactured to mimic EMPA 10 mg tablet.

Study Details

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.

Key Dates

Start date

Mar 31, 2016

Status verified

Jan 2020

Primary completion

Jan 31, 2018

Completion

Nov 30, 2018

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Empagliflozin
  Empagliflozin 10 mg by mouth daily for 3 months.
• Placebo Comparator: Placebo
  Placebo one tablet daily for 3 months

Primary Outcome Measure

Change in Glycerol Enrichment [ Time Frame: 3 months ]

Locations (1)

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