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

Completed

• Conditions: Obesity; Hypoglycemia

• Registration Number: NCT00998374
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Results First Submitted: 2014-01-27
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Serum Glucose Levels	30, 60, and 120 minutes at 6, 9, and 12 months post-operatively	Serum glucose levels measured to assess reactive hypoglycemia status
Reactive Hypoglycemia Status	6 months, 9 months, 12 months post-op	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

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance	6, 9, and 12 months post-operatively	Measured by levels of post prandial insulin
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing	6, 9, and 12 months post-op	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

Trial Locations

Locations (1)

Lenox Hill Hospital 186 E76th Street, 1st Floor; 🇺🇸 New York City, New York, United States