Erythrocyte and Adipocyte G6PD Activity Levels in Obesity

February 1, 2016 updated by: William Richards, University of South Alabama

Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity

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).

Study Overview

Status

Completed

Conditions

Detailed Description

Same as brief summary

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Mobile Infirmary Medical Center
      • Mobile, Alabama, United States, 36617
        • University of South Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients will be morbidly obese and undergo Roux-en-Y Gastric bypass surgery. Both Type 2 diabetic and non-diabetic patients will be accepted into the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure erythrocyte G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic Gastric Bypass.
Time Frame: time of surgery up to 24 months post gastric bypass
G6PD levels will be measured at the following time intervals: Baseline(prior to gastric bypass surgery), 1 week, 6 weeks, 12 weeks, 6 months, 12 months and 24 months post surgery.
time of surgery up to 24 months post gastric bypass

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure adipocyte G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic gastric bypass.
Time Frame: time of surgery up to 12 weeks post gastric bypass
time of surgery up to 12 weeks post gastric bypass
Measure omentum G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic gastric bypass.
Time Frame: time of surgery up to 12 weeks post gastric bypass
time of surgery up to 12 weeks post gastric bypass
Measure hepatocyte G6PD levels in diabetic vs. non-diabetic morbidly obese patients undergoing laparoscopic gastric bypass.
Time Frame: time of surgery up to 12 weeks post gastric bypass
time of surgery up to 12 weeks post gastric bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Alabama

Investigators

  • Principal Investigator: William O Richards, MD, University of South Alabama, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

March 23, 2011

First Posted (Estimate)

March 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe