Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome

Healthy Clinical Trial

Official title:

Dietary Sugar Hyper-absorptive Intestinal Phenotype as a Predictor of Weight Loss Post-bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408728
• Other study ID #: 22-001407
• Status: Recruiting
• Start date: July 10, 2022
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Dilhana Badurdeen, MBBS, MD
• Phone: 904-953-6970
• Email: Badurdeen.Dilhana[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Healthy
• Obese
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery		18 months
Secondary	Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery		18 months

External Links

•   Mayo Clinic Clinical Trials