Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome

NCT05408728 | Enrolling By Invitation

• 1 other identifier: 22-001407
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Healthy; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery

  18 months

Secondary Outcomes (1)

• Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery

  18 months

Study Arms (2)

Obese patients scheduled for Bariatric surgery

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.

Procedure: Endoscopic biopsy

Lean controls naive to Bariatric surgery

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.

Procedure: Endoscopic biopsy

Interventions

Endoscopic biopsy PROCEDURE

Upper small intestinal biopsies from patients undergoing BS will be collected during routine standard of care screening EGD and again from the same patients at 1 year during routine standard of care surveillance EGD (esophageal reflux screening/surveillance). Biopsy-derived enteroid cultures and tissue samples from pre- and one-year post BS will be examined for expression level of sugar transporters and gluconeogenic enzymes; glucose and fructose absorption

Lean controls naive to Bariatric surgery; Obese patients scheduled for Bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients scheduled for bariatric surgery (BS) (both men and women of any racial/ethnic background), or lean BS-naïve subjects presenting for surveillance/screening endoscopy procedure as part of their standard medical care (controls).

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Dilhana Badurdeen, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: July 10, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)