Diabetes Clinical Trial
Official title:
Profiling Extracellular Vesicle Cargo in Obesity and Type 2 Diabetes
| NCT number | NCT06401876 |
| Other study ID # | 21-003883 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 1, 2024 |
| Est. completion date | December 2026 |
| Verified date | May 2024 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 2026 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | Temple University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
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