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NCT Number: NCT07031297

Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal Study

Diagnostic Test

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 every 30 minutes following consumption of ensure for 4 hours.
  • Blood gasses will be drawn every 30 minutes for the 4 hours following the meal.

Participants will undergo a second abdominal adipose tissue biopsy 3 hours following mixed meal drink.

Primary outcomes

  1. Adipose tissue blood flow

    Time frame: 4 hours

    Blood flow will be measured in the upper body subcutaneous adipose tissue using Xenon washout and reported as blood flow in ml/min/100g adipose tissue.

Secondary outcomes

  1. Glucose

    Time frame: Baseline, 4 hours

    Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL, results reported in mg/dL

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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