Glucose IntoleranceNCT06401876
Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes
An observational study of Glucose Intolerance and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glucose Intolerance, Insulin Resistance, Diabetes
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Disqualified for Bariatric Surgery.
- BMI < 35 kg/m^2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Glucose Intolerance, Insulin Resistance, Diabetes
- Keywords
- Bariatric Surgical Procedure
- Medical subject headings
- Glucose Intolerance, Insulin Resistance, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Principal investigator, Michael A. Edwards, Mayo Clinic
- Investigators
- Michael Edwards, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401876
- Sponsor's protocol ID
- 21-003883
- Status last verified
- Aug 2025
- First submitted
- 2 May 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06401876
- Acronym / sponsor ID
- 21-003883
- Conditions
- Glucose Intolerance, Insulin Resistance, Diabetes
- Keywords
- Bariatric Surgical Procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Disqualified for Bariatric Surgery.
- BMI < 35 kg/m^2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Edwards, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Intolerance and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify circulating EV-derived protein and RNA signatures associated with T2D (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.