The Effects of Bariatric Surgeries on Glucose Metabolism (NCT02823665) | Clinical Trial Compass
RecruitingEarly Phase 1
The Effects of Bariatric Surgeries on Glucose Metabolism
United States200 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 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
* 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
What they're measuring
1
Insulin levels measured after nutrient ingestion
Timeframe: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
Trial details
NCT IDNCT02823665
SponsorThe University of Texas Health Science Center at San Antonio