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
  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:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Covidien
Investigators
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
Results First Received: January 27, 2014
Last Updated: March 19, 2014
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 July 26, 2014