Diabetes, Glucose Intolerance, Insulin Resistance
Conditions
Keywords
Bariatric Surgical Procedure
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
Interventions
None listed
Sponsors
Temple University
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify circulating EV-derived protein and RNA signatures associated with T2D | 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. | 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. |
Countries
United States
Outcome results
None listed