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

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ClinicalTrials.gov Identifier: NCT00998374
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hypoglycemia Obesity

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 Type : Observational
Actual Enrollment : 62 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Pyloric-sparing vs. non-pyloric sparing
Pyloric: SG & DS Non-pyloric: RYGB



Primary Outcome Measures :
  1. Mean Serum Glucose Levels [ Time Frame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively ]
    Serum glucose levels measured to assess reactive hypoglycemia status

  2. Reactive Hypoglycemia Status [ Time Frame: 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 :
  1. Insulin Resistance [ Time Frame: 6, 9, and 12 months post-operatively ]
    Measured by levels of post prandial insulin

  2. Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing [ Time Frame: 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



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients >18 years of age BMI greater than or equal to 35
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998374


Locations
United States, New York
Lenox Hill Hospital 186 E76th Street, 1st Floor
New York City, New York, United States, 10021
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Mitchell Roslin, MD Lenox Hill Hospital

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00998374     History of Changes
Other Study ID Numbers: AS08018
First Posted: October 20, 2009    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases