The Effects of Bariatric Surgeries on Glucose Metabolism
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Exendin-(9-39)
DrugA physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
Atropine
DrugA physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Exendin-(9-39)Experimental treatment 1 intervention
Group B: AtropineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov