Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome

Mayo Clinic

Status: Invitation-only

Conditions: Healthy; Obese; Bariatric Surgery Candidate

Treatments: Procedure: Endoscopic biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT05408728

22-001407

Details and patient eligibility

About

This study is trying to determine whether the success of bariatric surgery can be predicted by evaluating the dietary sugar absorptive characteristics in the small intestine and if there is any gene expression change on the dietary sugar absorptive characteristics.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obese patients (BMI ≥ 30) scheduled for BS undergoing standard of care screening EGD, or lean BS-naïve individuals (BMI ≤ 25) subjected to EGD for routine clinical indications as part of standard care.

Exclusion criteria

• Adults unable to consent, including non-English speakers.
• Pregnant women because endoscopy is a risk factor. All patients of childbearing age undergo history as well as urine pregnancy test as a standard of care prior to undergoing endoscopy as the procedure is performed under anesthesia.
• Prisoners.
• Subjects with preexisting conditions (e.g., bleeding at the time of the procedure, suspected perforation during the standard-of-care procedure) will be excluded from the study at the time of the endoscopy.
• Have a contraindication to endoscopy.
• A history of surgery on the stomach or small intestine.
• Type 1 diabetes (clinical diagnosis and/or positive glutamic acid decarboxylase antibodies).
• Using weight loss medications.
• Active malignancy within the last 5 years.

Trial design

52 participants in 2 patient groups

Obese patients scheduled for Bariatric surgery

Description:

Subjects scheduled for Bariatric Surgery (BS) and will receive pre-BS Esophagogastroduodenoscopy (EGD) as a part of your standard care will have biopsies from the small intestine taken during the EGD procedure for this study.

Treatment:

Procedure: Endoscopic biopsy

Lean controls naive to Bariatric surgery

Description:

Subjects presenting for surveillance/screening EGD procedure as part of their standard medical care will have biopsies from the small intestine taken during the EGD procedure for this study.

Treatment:

Procedure: Endoscopic biopsy