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

Medtronic

Status: Completed

Conditions: Hypoglycemia; Obesity

Study type: Observational

Funder types: Industry

Identifiers

NCT00998374

AS08018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

62 participants in 1 patient group

Pyloric-sparing vs. non-pyloric sparing

Description:

Pyloric: SG \& DS Non-pyloric: RYGB