Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
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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 |
- 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 ]
- 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 ]
| Enrollment: | 62 |
| Study Start Date: | September 2009 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Pyloric-sparing vs. non-pyloric sparing
Pyloric: SG & DS Non-pyloric: RYGB
|
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 |
Patients >18 years of age BMI greater than or equal to 35
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| United States, New York | |
| Lenox Hill Hospital 186 E76th Street, 1st Floor | |
| New York City, New York, United States, 10021 | |
| Principal Investigator: | Mitchell Roslin, MD | Lenox Hill Hospital |
More Information
No publications provided
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT00998374 History of Changes |
| Other Study ID Numbers: | AS08018 |
| Study First Received: | October 15, 2009 |
| Last Updated: | April 30, 2013 |
| 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 May 16, 2013