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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998374
• Other study ID #: AS08018
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: March 19, 2014
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoglycemia
• Obesity

Locations

Country	Name	City	State
United States	Lenox Hill Hospital 186 E76th Street, 1st Floor	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Serum Glucose Levels	Serum glucose levels measured to assess reactive hypoglycemia status	30, 60, and 120 minutes at 6, 9, and 12 months post-operatively	Yes
Primary	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	6 months, 9 months, 12 months post-op	Yes
Secondary	Insulin Resistance	Measured by levels of post prandial insulin	6, 9, and 12 months post-operatively	Yes
Secondary	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	6, 9, and 12 months post-op	No