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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Sugar Hyper-absorptive Intestinal Phenotype as a Predictor of Weight Loss Post-bariatric Surgery
- ClinicalTrials.gov ID
- NCT05408728
- Acronym / sponsor ID
- 22-001407
- Conditions
- Obese, Healthy, Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients scheduled for Bariatric surgery | – | Procedure: Endoscopic biopsySubjects 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 | – | Procedure: Endoscopic biopsySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic biopsyUpper 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 | Procedure or surgery | Lean controls naive to Bariatric surgery, Obese patients scheduled for Bariatric surgery |
Primary outcome
Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery
Time frame: 18 months
1 secondary outcome
Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dilhana Badurdeen, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese and Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.