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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal weight group

5 male and 5 female volunteers in normal weight range

Group Type OTHER

Meal Study

Intervention Type 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.

Obesity group

5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2)

Group Type OTHER

Meal Study

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes