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Erythrocyte and Adipocyte G6PD Activity Levels in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Richards, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01322035
First received: June 23, 2010
Last updated: January 17, 2013
Last verified: January 2013
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and tissue samples(adipose, omentum and liver biopsies)


Estimated Enrollment: 32
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Same as brief summary

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: William Richards, principal investigator, University of South Alabama
ClinicalTrials.gov Identifier: NCT01322035     History of Changes
Other Study ID Numbers: 09.0027
Study First Received: June 23, 2010
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 23, 2014