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

Medtronic - MITG62 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypoglycemia Obesity

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Serum Glucose Levels

Serum glucose levels measured to assess reactive hypoglycemia status

Time frame: 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

Time frame: 6 months, 9 months, 12 months post-op

Secondary Outcomes

Insulin Resistance

Measured by levels of post prandial insulin

Time frame: 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

Time frame: 6, 9, and 12 months post-op