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

NCT00178633 | Completed Results

• 2 other identifiers: HSC-MS-02-1375R01HL073162-02
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Diabetes; Heart Failure; Insulin Resistance

Keywords

Obesity; Insulin Resistance; Free Fatty Acids; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Change in weight. Negative values represent weight loss.

  0 to 9 months

Secondary Outcomes (3)

• Change in Glucose

  0-9 Months

• Change in Tissue Doppler Diastolic Velocity

  0-9 Months

• Change in Left Ventricular Mass

  0-9 Months

Study Arms (1)

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.

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

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

Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female, adult patients with clinically severe obesity who have undergone elective bariatric surgery.

You may qualify if:

• 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. .

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Texas, Health Sciences Center Houston

Houston, Texas, 77030, United States

Location

Related Publications (11)

• 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.

  PMID: 17138229 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.

  PMID: 16895880 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.

  PMID: 18954843 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.

  PMID: 19375553 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.

  PMID: 20394883 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.

  PMID: 16598541 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.

  PMID: 19356463 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.

  PMID: 20111021 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.

  PMID: 20093477 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.

  PMID: 20569762 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.

  PMID: 20676734 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skeletal muscle biopsies, plasma

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Heart Failure; Insulin Resistance

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Heinrich Taegtmeyer, MD, DPhil, Principal Investigator
• Organization: University of Texas Medical School at Houston

heinrich.taegtmeyer@uth.tmc.edu

713 500-6569

Study Officials

• Heinrich Taegtmeyer, MD, DPhil

  University of Texas, Health Sciences Center Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 23, 2020
• Results First Posted: September 11, 2014

Record last verified: 2020-11

Locations

US (1)