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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-04-30

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.

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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.

Conditions

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Hypoglycemia Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pyloric-sparing vs. non-pyloric sparing

Pyloric: SG \& DS Non-pyloric: RYGB

No interventions assigned to this group

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes