N/A
N=20
Changes in Ectopic Fat Following Surgically Induced Weight Loss
Obesity · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00840307 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Pancreatic and Liver Triglyceride (Fat) Content — 6.44; 2.08 percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pancreatic and Liver Triglyceride (Fat) Content |
6.44; 2.08 | — |
Summary
This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function.
Eligibility Criteria
Inclusion Criteria
- Greater than 18 years old
- Fully understanding and willing to undergo study procedures
- Available for follow-up
- Understand and willing to sign informed consent
- Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study
Exclusion Criteria
- Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
- Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
- History of pancreatic disease other than diabetes
- Regular use of more than 2 alcoholic drinks per day
- Pregnancy
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT00840307). 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.