Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Empagliflozin; Glycerol

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.