Phase 4
N=40
Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging
Obesity, Visceral
Bottom Line
View on ClinicalTrials.gov: NCT02833415 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Change in Glycerol Enrichment — 6.5; 1.4 Percentage change — p=0.0053
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- [U-13C3] glycerol (Drug); Empagliflozin (Drug); Placebo (for Empagliflozin) (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycerol Enrichment |
6.5; 1.4 | 0.0053 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02833415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.