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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL073162-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post bariatric surgery. While all 43 patients reportedly completed 3 and 9 month evaluations, only 15 patients completed 24 month evaluations due to 28 patients unwilling to return.
The overarching purpose appears to have been not only evaluation of weightloss, but normalization of metabolic profile over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery | Procedures were not part of the trial. Patients already undergoing these clinical procedures agreed to analysis and follow-up for research purposes. All patients had one of two different types of procedures, but outcome analyses did not distinguish between the two procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Change in weight. Negative values represent weight loss. | 0 to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glucose | Change in glucose. Negative values represent a decrease in glucose levels. | 0-9 Months |
| Change in Tissue Doppler Diastolic Velocity | Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity. |
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Inclusion Criteria:
Patients who have components of the metabolic syndrome (hypertension, diabetes, and dyslipidemia) will be included if these complications do not preclude a safe operation. .
Exclusion Criteria: Exclusion criteria include age over 70 years, current history of smoking, coronary artery disease, congestive heart failure, ischemic cardiomyopathy, known peripheral vascular disease, severe psychiatric disease, any medical problem or physical contraindication for surgery (as determined by the physician) and pregnancy. This study will be limited to adults since the safety of gastric bypass surgery has not been shown to be safe in children in large clinical trials
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Male and female, adult patients with clinically severe obesity who have undergone elective bariatric surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Heinrich Taegtmeyer, MD, DPhil | University of Texas, Health Sciences Center Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas, Health Sciences Center Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17138229 | Result | Leichman JG, Aguilar D, King TM, Mehta S, Majka C, Scarborough T, Wilson EB, Taegtmeyer H. Improvements in systemic metabolism, anthropometrics, and left ventricular geometry 3 months after bariatric surgery. Surg Obes Relat Dis. 2006 Nov-Dec;2(6):592-9. doi: 10.1016/j.soard.2006.09.005. | |
| 16895880 | Result | Leichman JG, Aguilar D, King TM, Vlada A, Reyes M, Taegtmeyer H. Association of plasma free fatty acids and left ventricular diastolic function in patients with clinically severe obesity. Am J Clin Nutr. 2006 Aug;84(2):336-41. doi: 10.1093/ajcn/84.1.336. |
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IRB Approved to begin recruitment, 5.20.2004. Enrollment ended June 2006. All patients recruited from University of Texas Houston, Bariatric Surgery Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bariatric Surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
43 patients were originally enrolled, and 37 participated through 9 months; 15 female participants returned for an additional 2 year analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bariatric Surgery | Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Change in weight. Negative values represent weight loss. | broken out into 0-3months and 3-9months below | Posted | Mean | 95% Confidence Interval | kg | 0 to 9 months |
|
|
Adverse event data were collected at both 9 months and 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bariatric Surgery, Follow up at 9 Months | Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heinrich Taegtmeyer, MD, DPhil, Principal Investigator | University of Texas Medical School at Houston | 713 500-6569 | heinrich.taegtmeyer@uth.tmc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Skeletal muscle biopsies, plasma
| 0-9 Months |
| Change in Left Ventricular Mass | Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass. | 0-9 Months |
| 18954843 | Result | Leichman JG, Wilson EB, Scarborough T, Aguilar D, Miller CC 3rd, Yu S, Algahim MF, Reyes M, Moody FG, Taegtmeyer H. Dramatic reversal of derangements in muscle metabolism and left ventricular function after bariatric surgery. Am J Med. 2008 Nov;121(11):966-73. doi: 10.1016/j.amjmed.2008.06.033. |
| 19375553 | Result | Trakhtenbroit MA, Leichman JG, Algahim MF, Miller CC 3rd, Moody FG, Lux TR, Taegtmeyer H. Body weight, insulin resistance, and serum adipokine levels 2 years after 2 types of bariatric surgery. Am J Med. 2009 May;122(5):435-42. doi: 10.1016/j.amjmed.2008.10.035. |
| 20394883 | Result | Taegtmeyer H, Leichman JG, Reyes M, Lux TR. Early benefits from weight-loss surgery. J Am Coll Cardiol. 2010 Apr 20;55(16):1754; author reply 1754. doi: 10.1016/j.jacc.2009.11.081. No abstract available. |
| 16598541 | Result | Leichman JG, Lavis VR, Aguilar D, Wilson CR, Taegtmeyer H. The metabolic syndrome and the heart--a considered opinion. Clin Res Cardiol. 2006 Jan;95 Suppl 1:i134-41. doi: 10.1007/s00392-006-1119-7. |
| 19356463 | Result | Taegtmeyer H, Algahim MF. Obesity and cardiac metabolism in women. JACC Cardiovasc Imaging. 2008 Jul;1(4):434-5. doi: 10.1016/j.jcmg.2008.04.008. No abstract available. |
| 20111021 | Result | Burgmaier M, Sen S, Philip F, Wilson CR, Miller CC 3rd, Young ME, Taegtmeyer H. Metabolic adaptation follows contractile dysfunction in the heart of obese Zucker rats fed a high-fat "Western" diet. Obesity (Silver Spring). 2010 Oct;18(10):1895-901. doi: 10.1038/oby.2009.500. Epub 2010 Jan 28. |
| 20093477 | Result | Harmancey R, Wilson CR, Wright NR, Taegtmeyer H. Western diet changes cardiac acyl-CoA composition in obese rats: a potential role for hepatic lipogenesis. J Lipid Res. 2010 Jun;51(6):1380-93. doi: 10.1194/jlr.M001230. Epub 2010 Jan 21. |
| 20569762 | Result | Algahim MF, Lux TR, Leichman JG, Boyer AF, Miller CC 3rd, Laing ST, Wilson EB, Scarborough T, Yu S, Snyder B, Wolin-Riklin C, Kyle UG, Taegtmeyer H. Progressive regression of left ventricular hypertrophy two years after bariatric surgery. Am J Med. 2010 Jun;123(6):549-55. doi: 10.1016/j.amjmed.2009.11.020. |
| 20676734 | Result | Ballal K, Wilson CR, Harmancey R, Taegtmeyer H. Obesogenic high fat western diet induces oxidative stress and apoptosis in rat heart. Mol Cell Biochem. 2010 Nov;344(1-2):221-30. doi: 10.1007/s11010-010-0546-y. Epub 2010 Jul 31. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Glucose | Change in glucose. Negative values represent a decrease in glucose levels. | broken out into 0-3months and 3-9months below | Posted | Mean | 95% Confidence Interval | mg/dL | 0-9 Months |
|
|
|
| Secondary | Change in Tissue Doppler Diastolic Velocity | Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity. | Analysis broken down into 0-3 months and 3-9 months | Posted | Mean | 95% Confidence Interval | cm/s | 0-9 Months |
|
|
|
| Secondary | Change in Left Ventricular Mass | Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass. | broken out into 0-3months and 3-9months below | Posted | Mean | 95% Confidence Interval | g/m^2.7 | 0-9 Months |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Bariatric Surgery, Follow up at 2 Years | Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes. | 0 | 19 | 0 | 19 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |