Early Diabetes Resolution After Weight Loss Surgery
This study is enrolling participants by invitation only.
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00790309
First received: November 11, 2008
Last updated: June 8, 2012
Last verified: June 2012
Tracking Information | |||||
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First Received Date ICMJE | November 11, 2008 | ||||
Last Updated Date | June 8, 2012 | ||||
Start Date ICMJE | December 2008 | ||||
Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00790309 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Early Diabetes Resolution After Weight Loss Surgery | ||||
Official Title ICMJE | Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery | ||||
Brief Summary | The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population. |
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Detailed Description | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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Biospecimen | Retention: Samples With DNA Description: plasma and serum |
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Sampling Method | Non-Probability Sample | ||||
Study Population | Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered for the study. |
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Condition ICMJE |
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Intervention ICMJE |
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Study Group/Cohort (s) |
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Publications * | |||||
* 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 | Enrolling by invitation | ||||
Estimated Enrollment ICMJE | 60 | ||||
Estimated Completion Date | November 2012 | ||||
Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00790309 | ||||
Other Study ID Numbers ICMJE | NNA-Early DM Resolution | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Naji Abumrad, Vanderbilt University | ||||
Study Sponsor ICMJE | Vanderbilt University | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Vanderbilt University | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |