Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes

The purpose of this research is to obtain blood samples before and after a bariatric procedure to better understand the reasons for glucose intolerance and insulin resistance (diabetes) in the obesity, and the reasons for improvement of diabetes after bariatric surgery

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Key information

Conditions

Glucose Intolerance Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Enrolled in the Bariatric Surgery Program.
Patients with A1c of 6.5 or higher within the last 6 months. OR
Patients with A1c less than 6.5; have diagnosis of stable type 2 diabetes for > 6 months.

Exclusion criteria

Disqualified for Bariatric Surgery.
BMI < 35 kg/m^2.

Treatment and study plan

Primary outcomes

Identify circulating EV-derived protein and RNA signatures associated with T2D

Time frame: 1 year

Circulating EVs will be isolated from plasma samples from patients with extreme obesity, with either T2D or normoglycemia. EV-derived proteins will be analyzed by shotgun proteomics using mass spectrometry and RNA by sequencing or microarray RNA technology to identify differential abundance between T2D and normoglycemia.
Identify changes in circulating EV cargo in patients whose T2D resolves after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) or duodenal switch procedures.

Time frame: 1 year

Plasma samples will be prospectively obtained from patients recruited in Aim 1 at baseline and within four weeks and at one-year after SG, RYGB or Duodenal Switch Procedures. EVs will be isolated, and protein and RNA profiled as described in Aim 1. Changes in EV cargo from baseline to one-year post-SG or RYGB and T2D remission will be assessed.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Temple University

Registry information

Official study title

Profiling Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 7, 2024
Registry last updated: Aug 20, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed