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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01322035
Other study ID # 09.0027
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2009
Est. completion date March 2013

Study information

Verified date May 2024
Source University of South Alabama
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).


Description:

Same as brief summary


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: - Age > 19 years of age and <70 years of age - HGA1c<6.0% - fasting blood sugar less than 100mg/dL Exclusion Criteria: - Taking antidiabetic medications for other indications

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mobile Infirmary Medical Center Mobile Alabama
United States University of South Alabama Mobile Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure Erythrocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress. G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.
Secondary Measure Adipocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. G6PD levels will be measured various time intervals. G6PD is the rate limiting enzyme of the pentose phosphate pathway that provides NADPH required for lipid synthesis. G6PD overexpression is implicated in insulin resistance, hyperlipidemia and increases in oxidative stress. G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, and 12 weeks post surgery.
Secondary Measure Omentum G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. time of gastric bypass
Secondary Measure Hepatocyte G6PD Levels in Diabetic vs. Non-diabetic Morbidly Obese Patients Undergoing Laparoscopic Gastric Bypass. time of gastric bypass
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