Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes

August 18, 2025 updated by: Michael A. Edwards, Mayo Clinic

Profiling 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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is open to patients aged 21 years or older who have a BMI of 35 kg/m2 or more and are planning to undergo bariatric surgery. Patients must have an A1c of 6.5 or higher measured within the last 6 months or if A1C is less than 6.5 must have a diagnosis of stable type 2 diabetes for more than 6 months.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Temple University

Investigators

  • Principal Investigator: Michael Edwards, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-003883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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