Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

Study Overview
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Brief Summary
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This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.

Detailed Description
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Clinical Trial Objective: The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate. Clinical Trial Design: This is a prospective, non-randomized, clinical trial.

Official Title
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Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

Conditions
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Hypoglycemia, Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is greater than 18 years old; The patient has a BMI > 35; Patient meets standards for bariatric surgery; Exclusion Criteria: The patient has an incurable malignant or debilitating disease; The patient has been diagnosed with a severe eating disorder; The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years); The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent

Ages Eligible for Study
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Minimum Age: 19 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pyloric-sparing vs. non-pyloric sparing<br>Pyloric: SG & DS Non-pyloric: RYGB | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Serum Glucose Levels | Serum glucose levels measured to assess reactive hypoglycemia status | 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively | 
| Reactive Hypoglycemia Status | Postoperative reactive hypoglycemia was defined as either serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing | 6 months, 9 months, 12 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance | Measured by levels of post prandial insulin | 6, 9, and 12 months post-operatively | 
| Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing | Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response | 6, 9, and 12 months post-op |