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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00998374
First received: October 15, 2009
Last updated: March 19, 2014
Last verified: March 2014

October 15, 2009
March 19, 2014
September 2009
January 2013   (final data collection date for primary outcome measure)
  • Mean Serum Glucose Levels [ Time Frame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively ] [ Designated as safety issue: Yes ]
    Serum glucose levels measured to assess reactive hypoglycemia status
  • Reactive Hypoglycemia Status [ Time Frame: 6 months, 9 months, 12 months post-op ] [ Designated as safety issue: Yes ]

    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
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 ]
Complete list of historical versions of study NCT00998374 on ClinicalTrials.gov Archive Site
  • Insulin Resistance [ Time Frame: 6, 9, and 12 months post-operatively ] [ Designated as safety issue: Yes ]
    Measured by levels of post prandial insulin
  • Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing [ Time Frame: 6, 9, and 12 months post-op ] [ Designated as safety issue: No ]
    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
  • 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 ]
Not Provided
Not Provided
 
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients >18 years of age BMI greater than or equal to 35

  • Hypoglycemia
  • Obesity
Not Provided
Pyloric-sparing vs. non-pyloric sparing
Pyloric: SG & DS Non-pyloric: RYGB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
April 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998374
AS08018
No
Covidien
Covidien
Not Provided
Principal Investigator: Mitchell Roslin, MD Lenox Hill Hospital
Covidien
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP