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Erythrocyte and Adipocyte G6PD Activity Levels in Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322035
First Posted: March 24, 2011
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Richards, University of South Alabama
  Purpose
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).

Condition
Diabetes Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity

Resource links provided by NLM:


Further study details as provided by William Richards, University of South Alabama:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Biospecimen Retention:   Samples With DNA
Blood and tissue samples(adipose, omentum and liver biopsies)

Enrollment: 16
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:
Same as brief summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322035


Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
University of South Alabama
Mobile, Alabama, United States, 36617
Sponsors and Collaborators
University of South Alabama
Investigators
Principal Investigator: William O Richards, MD University of South Alabama, Department of Surgery
  More Information

Responsible Party: William Richards, principal investigator, University of South Alabama
ClinicalTrials.gov Identifier: NCT01322035     History of Changes
Other Study ID Numbers: 09.0027
First Submitted: June 23, 2010
First Posted: March 24, 2011
Last Update Posted: February 3, 2016
Last Verified: January 2013

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms