Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07031297

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Meal Study

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT07031297

Start date

May 5, 2026

Status verified date

Jul, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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)

Interventions

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 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 outcome measure

  • Adipose tissue blood flow [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Kelli A. Lytle, Ph.D.

507-255-1488lytle.kelli@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Kelli A Lytle

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.