Post Bariatric SurgeryEarly Phase 1NCT02823665
The Effects of Bariatric Surgeries on Glucose Metabolism
A Early Phase 1 study testing Exendin-(9-39) and Atropine in people with Post Bariatric Surgery and Gastric Bypass, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy
- What is being tested?
- Exendin-(9-39) and Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Aug 2027
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
- Asymptomatic individuals with bariatric surgery
- Healthy non-surgical patients with no personal history of diabetes
- Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center
Who cannot join
- Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
- RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
- Healthy non-surgical patients with personal history of diabetes
- For administration of atropine, the following exclusions also apply:
- History of glaucoma
- Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia
Show all 10Show fewer
- Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
- Myasthenia gravis
- Brain pathology
- Enlarged prostate in men
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
Marzieh Salehi, MD, 210-567-6691, hansisdiarte@uthscsa.edu
Jennifer Foster, MSN, 210-450-8696, fosterj6@uthscsa.edu
- Recruiting
South Texas Veterans Health Care System
San Antonio, Texas, 78229
Marzieh Salehi, MD, 210-567-6691, salehi@uthscsa.edu
Jennifer Foster, MSN, 210-450-8696, fosterj6@uthscsa.edu
About this study
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.
Read the detailed description
The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures.
Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.
- Conditions
- Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass
- Being tested
- Exendin-(9-39), Atropine
- Keywords
- gastric bypass surgery, Hypoglycemia, sleeve gastrectomy, glucose tolerance
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin-(9-39)Drug
Also called no other name for Exendin-(9-39)
A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
AtropineDrug
Also called Atropine sulfate
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
| Study group | Role | What they receive |
|---|---|---|
| Exendin-(9-39) | Experimental | To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion. Receives: Drug: Exendin-(9-39) |
| Atropine | Experimental | to evaluate the effect of neural activation on insulin secretion and glucose metabolism Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin levels measured after nutrient ingestion
Measured: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marzieh Salehi, MD, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823665
- Sponsor's protocol ID
- 20180070H
- Other IDs
- 1R01DK105379-01
- Status last verified
- Sep 2025
- First submitted
- 22 Oct 2015
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bariatric Surgeries on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02823665
- Acronym / sponsor ID
- 20180070H
- Conditions
- Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass
- Keywords
- gastric bypass surgery, Hypoglycemia, sleeve gastrectomy, glucose tolerance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2015
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- 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.
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.
Detailed description
The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures.
Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exendin-(9-39) | Experimental | Drug: Exendin-(9-39)To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion. |
| Atropine | Experimental | Drug: Atropineto evaluate the effect of neural activation on insulin secretion and glucose metabolism |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
- Asymptomatic individuals with bariatric surgery
- Healthy non-surgical patients with no personal history of diabetes
- Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center
Key exclusion criteria (10 listed)
- Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
- RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
- Healthy non-surgical patients with personal history of diabetes
- History of glaucoma
- Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia
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 |
|---|---|---|
| Exendin-(9-39)Also: no other name for Exendin-(9-39)A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion. | Drug | Exendin-(9-39) |
| AtropineAlso: Atropine sulfateA physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism. | Drug | Atropine |
Primary outcome
Insulin levels measured after nutrient ingestion
Time frame: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
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 9 Sep 2025.
- 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.
Marzieh Salehi, MD, MS principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exendin-(9-39) and Atropine in people with Post Bariatric Surgery and Gastric Bypass, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Marzieh Salehi, MD MS (210-567-6691, salehi@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin levels measured after nutrient ingestion (time frame: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.). 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 9 Sep 2025.