Phase 4
Completed N=40
Visceral Adiposity and Diabetes: Translating Form to Function Using Imaging
Obesity, Visceral
Source: ClinicalTrials.gov NCT02833415 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change in Glycerol Enrichment — 6.5; 1.4 Percentage change — p=0.0053
◆ Published Evidence
Established
30citations · ~5 / year
Effects of Empagliflozin Treatment on Glycerol-Derived Hepatic Gluconeogenesis in Adults with Obesity: A Randomized Clinical Trial.
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.
Linked Publications
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Effects of Empagliflozin Treatment on Glycerol-Derived Hepatic Gluconeogenesis in Adults with Obesity: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycerol Enrichment |
6.5; 1.4 | 0.0053 sig |
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) and the linked publication. 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. Informational only — not medical advice.