Investigating how neural and hormonal factors affect insulin secretion after gastric bypass surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the role of neural and gastrointestinal (GI) hormones in insulin secretion among patients who have undergone Roux-en-Y gastric bypass (RYGB) surgery. It aims to understand how these factors contribute to improved glucose metabolism and the occurrence of hypoglycemia in RYGB patients. The study will compare insulin responses in hypoglycemic RYGB patients, asymptomatic RYGB patients, and healthy non-surgical controls. Various interventions, including GLP-1 and atropine, will be administered to assess their effects on islet cell function and responsiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Texas Diabetes Institute - University Health System
  San Antonio, Texas, United States Recruiting
• South Texas Veterans Health Care System
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Marzieh Salehi, MD, MS — Marzieh Salehi
• Study coordinator: Marzieh Salehi, MD MS
• Email: salehi@uthscsa.edu
• Phone: 210-567-6691

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.