Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging

Completed · Phase 4 · Has a placebo group

Conditions studied: Obesity, Visceral

In brief

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 facts

Study ID

NCT02833415

Run by

University of Texas Southwestern Medical Center

People needed

40

Starts

2016-03-01

Expected to finish

2018-11-01

Last updated by the study team

2020-01-23

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Obese, defined as BMI ≥ 30 kg/m2, at both time of abdominal fat imaging and at study entry.
• Ages 30-65
• No prevalent diagnosis of type 2 diabetes mellitus, either at the time of abdominal fat imaging or at study entry.
• Previous abdominal fat quantification by magnetic resonance imaging in the Dallas Heart Study or possible neck-to-knee MRI for VAT measurement may be performed.

You may not qualify if…

• Pregnant or breastfeeding
• Incarcerated
• Chronic kidney or liver disease
• History of frequent (>2/year) urinary tract infections
• Non-obese either at time of abdominal fat imaging or at present.
• Greater than 10% change in body weight (kg) between time of abdominal fat imaging and present.
• Has donated blood within last 6 weeks
• Cannot give informed consent, understand the protocol, or tolerate any aspect of the protocol
• If undergoing MRI, persons with metal implants contraindicated for 3Tesla MRI exams will be excluded. Severe claustrophobia will also be assessed prior to an MRI exam.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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