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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00998374
Other study ID # AS08018
Secondary ID
Status Completed
Phase N/A
First received October 15, 2009
Last updated March 19, 2014
Start date September 2009
Est. completion date April 2013

Study information

Verified date March 2014
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Lenox Hill Hospital 186 E76th Street, 1st Floor New York City New York

Sponsors (1)

Lead Sponsor Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Serum Glucose Levels Serum glucose levels measured to assess reactive hypoglycemia status 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively Yes
Primary Reactive Hypoglycemia Status 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
6 months, 9 months, 12 months post-op Yes
Secondary Insulin Resistance Measured by levels of post prandial insulin 6, 9, and 12 months post-operatively Yes
Secondary Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing 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 6, 9, and 12 months post-op No
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