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

Completed

Conditions studied: Hypoglycemia, Obesity

In brief

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.

Key facts

Study ID

NCT00998374

Run by

Medtronic - MITG

People needed

62

Starts

2009-09-01

Expected to finish

2013-04-01

Last updated by the study team

2014-04-21

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The patient is greater than 18 years old;
• The patient has a BMI > 35;
• Patient meets standards for bariatric surgery;

You may not qualify if…

• 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

Where it is running

• Lenox Hill Hospital 186 E76th Street, 1st Floor — New York, New York, United States

Full record on ClinicalTrials.gov

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