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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor: Mayo Clinic
Study ID: NCT07031297
Status: Recruiting

Apply to this trial

Conditions

Obesity

Eligibility Criteria

Sex: ALL
Age: 18 Years - 55 Years
Healthy Volunteers: Accepted

Interventions

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.

Study Details

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.

Key Dates

First listed: Jun 22, 2025
Start date: May 5, 2026
Status verified: Jul 2026
Primary completion: May 31, 2028
Completion: May 31, 2028

Study Design

Enrollment: 20 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Arms

Other: Normal weight group
5 male and 5 female volunteers in normal weight range
Other: Obesity group
5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2)