The Effects of Bariatric Surgeries on Glucose Metabolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Bariatric Surgeries on Glucose Metabolism

Conditions
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Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass

Intervention / Treatment
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* Drug: Exendin-(9-39)
* Drug: Atropine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exendin-(9-39)<br>To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion. | Drug: Exendin-(9-39)<br>* A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.<br>* Other names: no other name for Exendin-(9-39);|
| Experimental: Atropine<br>to evaluate the effect of neural activation on insulin secretion and glucose metabolism | Drug: Atropine<br>* A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.<br>* Other names: Atropine sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin levels measured after nutrient ingestion |  | Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric bypass surgery, Hypoglycemia, sleeve gastrectomy, glucose tolerance