ObeseNCT05408728
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
An observational study of Obese and Healthy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obese, Healthy, Bariatric Surgery Candidate
- What is being tested?
- Endoscopic biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- Type 1 diabetes (clinical diagnosis and/or positive glutamic acid decarboxylase antibodies).
- Using weight loss medications.
- Active malignancy within the last 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dietary Sugar Hyper-absorptive Intestinal Phenotype as a Predictor of Weight Loss Post-bariatric Surgery
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
- Being tested
- Endoscopic biopsy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic biopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery
Measured: 18 months
Secondary outcomes (1)
Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jul 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilhana S. Badurdeen, Mayo Clinic
- Investigators
- Dilhana Badurdeen, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408728
- Sponsor's protocol ID
- 22-001407
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No