Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome

• Conditions: Bariatric Surgery Candidate; Healthy; Obese
• Interventions: Procedure: Endoscopic biopsy

• Registration Number: NCT05408728
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-07-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients scheduled for Bariatric surgery	Endoscopic biopsy	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.
Lean controls naive to Bariatric surgery	Endoscopic biopsy	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.

Primary Outcome Measures

Name	Time	Method
Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery	18 months

Secondary Outcome Measures

Name	Time	Method
Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery	18 months

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States