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Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery

NCT ID: NCT00178633

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Diabetes Heart Failure Insulin Resistance

Keywords

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Obesity Insulin Resistance Free Fatty Acids Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bariatric surgery

Intervention Type PROCEDURE

Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.

Interventions

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Bariatric surgery

Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The subjects in this study will represent both male and female patients with clinically severe obesity (BMI \> 40kg/m2 or 35kg/m2 with significant obesity related co-morbidities), who have chosen to undergo elective bariatric surgery. Patients are screened through the University of Texas Houston Bariatric Surgery Center (UTHBSC) and are evaluated for bariatric surgery, defined in this study as small pouch gastric bypass with Roux-en-Y (SPGB), or laparoscopic adjustable gastric banding (LAGB). Adults (\>18)from diverse ethnic backgrounds, with clinically severe obesity, are eligible to be evaluated for bariatric weight loss surgery in the UTHBSC. Candidates considered for the study are patients who not only fulfill the criteria for weight loss surgery, but also demonstrate a high likelihood of complying with the long-term follow-up that is required for a successful study.

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heinrich Taegtmeyer, MD, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Health Sciences Center Houston

Locations

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University of Texas, Health Sciences Center Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17138229 (View on PubMed)

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.

Reference Type RESULT
PMID: 16895880 (View on PubMed)

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.

Reference Type RESULT
PMID: 18954843 (View on PubMed)

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.

Reference Type RESULT
PMID: 19375553 (View on PubMed)

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.

Reference Type RESULT
PMID: 20394883 (View on PubMed)

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.

Reference Type RESULT
PMID: 16598541 (View on PubMed)

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.

Reference Type RESULT
PMID: 19356463 (View on PubMed)

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.

Reference Type RESULT
PMID: 20111021 (View on PubMed)

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.

Reference Type RESULT
PMID: 20093477 (View on PubMed)

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.

Reference Type RESULT
PMID: 20569762 (View on PubMed)

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.

Reference Type RESULT
PMID: 20676734 (View on PubMed)

Other Identifiers

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5R01HL073162-02

Identifier Type: NIH

Identifier Source: secondary_id

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HSC-MS-02-137

Identifier Type: -

Identifier Source: org_study_id