Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic biopsy.
- Who it may be relevant to
- Registry conditions: Obese, Healthy, Bariatric Surgery Candidate. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dietary Sugar Hyper-absorptive Intestinal Phenotype as a Predictor of Weight Loss Post-bariatric Surgery
Overview
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.
Interventions
- Procedure Endoscopic biopsy
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
Primary outcome measures
- Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery [Time frame: 18 months]
Secondary outcome measures (1)
- Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery [Time frame: 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Identifiers
NCT: NCT05408728 · 22-001407