Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes

NCT06401876 | Completed

• 1 other identifier: 21-003883
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glucose Intolerance; Insulin Resistance; Diabetes

Keywords

Bariatric Surgical Procedure

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Temple University: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Endocrine System Diseases

Study Officials

• Michael Edwards, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)