Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meal Study.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal
Overview
The purpose of this study is to understand the specific outflow and difference between normal weight and volunteers with obesity of upper body subcutaneous adipose tissue in response to a mixed meal challenge by site specific cannulation of the superior epigastric vein. We will characterize the exosome signatures in response to a meal and compare to the exosome signature of arterialized venous plasma samples.
Interventions
- Diagnostic test Meal Study
Participants will consume a mixed meal drink (Ensure) equivalent to 40% of basil metabolic rate as calculated via Harris Benedict equation. Following consumption of the drink they will undergo a series of blood draws over the following 4 hours: * Plasma glucose will be measured according to a mixed meal test protocol every 10 minutes for the first hour and then every 15, then 30 minutes for the last 3 hours. * 1 ml plasma aliquots for exosome analysis and insulin concentrations will be drawn e
Primary outcome measures
- Adipose tissue blood flow [Time frame: 4 hours]
Secondary outcome measures (1)
- Glucose [Time frame: Baseline, 4 hours]
Eligibility criteria
Inclusion criteria
- All women must be premenopausal
Exclusion criteria
- Participants taking medications know to affect blood flow (statins, β-blockers) or fatty acid or adipose tissue metabolism (TZDs, high dose fish oil supplements)
- Diabetes, history of cardiovascular disease
- Allergy to lidocaine
- Post-menopausal women
- Pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07031297 · 24-007465