Erythrocyte and Adipocyte G6PD Activity Levels in Obesity
This study is ongoing, but not recruiting participants.
Sponsor:
University of South Alabama
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 23, 2010 | ||||
| Last Updated Date | January 17, 2013 | ||||
| Start Date ICMJE | December 2009 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01322035 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Erythrocyte and Adipocyte G6PD Activity Levels in Obesity | ||||
| Official Title ICMJE | Erythrocyte and Adipocyte G6PD Activity Levels Correlate With Differing Degrees of Dyslipidemia, Insulin Resistance and Obesity | ||||
| Brief 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). |
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| Detailed Description | Same as brief summary |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood and tissue samples(adipose, omentum and liver biopsies) |
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| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01322035 | ||||
| Other Study ID Numbers ICMJE | 09.0027 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | William Richards, University of South Alabama | ||||
| Study Sponsor ICMJE | University of South Alabama | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of South Alabama | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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