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

Sponsor:	Covidien
Information provided by:	Covidien
ClinicalTrials.gov Identifier:	NCT00998374

Purpose

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
Hypoglycemia Obesity

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Hypoglycemia Obesity Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:

Reactive hypoglycemia status and ratio between the maximum serum glucose level and the minimum serum glucose level during glucose tolerance testing. [ Time Frame: 6, 9, and 12 months post-operatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Insulin resistance [ Time Frame: 6, 9, and 12 months post-operatively ] [ Designated as safety issue: Yes ]
subjective symptoms of hypoglycemia during glucose tolerance testing [ Time Frame: 6, 9, and 12 months post-op ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2009
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Pyloric-sparing group vs. non-pyloric sparing group Pylorus sparing = sleeve gastrectomy and duodenal switch procedures Non-pylorus sparing = gastric bypass procedure

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998374

Contacts

Contact: JoAnne Weiskopf, RPA-C	212-434-3285	jweiskopf@lenoxhill.net
Contact: Yuriy Dudiy	718-501-0284	ydudiy@lenoxhill.net

Locations

United States, New York
Lenox Hill Hospital 186 E76th Street, 1st Floor	Recruiting
New York City, New York, United States, 10021

Sponsors and Collaborators

Covidien

Investigators

Principal Investigator:

Mitchell Roslin, MD

Lenox Hill Hospital

More Information

No publications provided

Responsible Party:	Mitchell Roslin, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier:	NCT00998374 History of Changes
Other Study ID Numbers:	AS08018
Study First Received:	October 15, 2009
Last Updated:	April 5, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hypoglycemia
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition

Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012