N/A
N=62
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
Hypoglycemia · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00998374 ↗Enrolled (actual)
62
Serious AEs
12.9%
Results posted
Apr 2014
Primary outcome: Primary: Mean Serum Glucose Levels — 123.1; 157.5; 103.2; 138 mg/dl
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Serum Glucose Levels |
123.1; 157.5; 103.2; 138; 130.3; 173.4 | — |
| PRIMARY Reactive Hypoglycemia Status |
11; 6; 4; 3; 7; 7 | — |
| SECONDARY Insulin Resistance |
13.7; 21.2; 6.4; 20.9; 10.9; 16.7 | — |
| SECONDARY Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing |
6; 8; 1; 3; 2; 6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00998374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.