RecruitingPhase EARLY_1

Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery

Hormonal and Neural Control of Insulin Secretion Following Gastric Bypass Surgery

Lead sponsor

The University of Texas Health Science Center at San Antonio

Asset

Avexitide

Listed sites

Recruiting sites

Estimated enrollment

160

Study population

Eligibility highlights

•Healthy volunteers

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00992901

Org study ID18-070H

Secondary IDDK083554NIDDK

Timeline

Milestones

Study first posted2009-10-09estimated

Last update posted2025-09-09actual

Study start2009-10 (month precision)

Primary completion2026-08estimated (month precision)

Study completion2027-08estimated (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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 at Cedars-Sinai Medical Center

Exclusion criteria

•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 melitis; development of any serious medical or psychiatric illness during recruitment or studies;

•RYGB patients will also 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

•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

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.