ObesityNCT00178633
Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery
An observational study of Obesity and Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Diabetes, Heart Failure
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Aug 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female, adult patients with clinically severe obesity who have undergone elective bariatric surgery.
Who may be able to join
- 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: 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas, Health Sciences Center Houston
Houston, Texas, 77030
About this study
Official title: Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery
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
- Being tested
- Bariatric surgery
- Keywords
- Obesity, Insulin Resistance, Free Fatty Acids, Heart Failure
- Medical subject headings
- Obesity, Diabetes Mellitus, Heart Failure, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight. Negative values represent weight loss.
Measured: 0 to 9 months
Secondary outcomes (3)
Change in Glucose
Change in glucose. Negative values represent a decrease in glucose levels.
Measured: 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.
Measured: 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.
Measured: 0-9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Heinrich Taegtmeyer, MD, DPhil, Principal investigator, University of Texas, Health Sciences Center Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178633
- Sponsor's protocol ID
- HSC-MS-02-137
- Other IDs
- 5R01HL073162-02
- Status last verified
- Nov 2020
- First submitted
- 12 Sep 2005
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17138229Leichman 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.
PubMed 16895880Leichman 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.
PubMed 18954843Trakhtenbroit 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.
PubMed 19375553Taegtmeyer 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.
PubMed 20394883Leichman 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.
PubMed 16598541Taegtmeyer 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.
PubMed 19356463Burgmaier 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.
PubMed 20111021Harmancey 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.
PubMed 20093477Algahim 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.
PubMed 20569762Ballal 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.
PubMed 20676734
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00178633
- Acronym / sponsor ID
- HSC-MS-02-137
- Conditions
- Obesity, Diabetes, Heart Failure, Insulin Resistance
- Keywords
- Obesity, Insulin Resistance, Free Fatty Acids, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | – | Procedure: Bariatric surgeryProcedures 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female, adult patients with clinically severe obesity who have undergone elective bariatric surgery.
Key inclusion criteria (4 listed)
- 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: 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryBariatric surgery was not part of this trial. This was observational trial of persons post-bariatric surger. | Procedure or surgery | Bariatric Surgery |
Primary outcome
Change in Weight
Time frame: 0 to 9 months
Change in weight. Negative values represent weight loss.
3 secondary outcomes
Change in Glucose
Time frame: 0-9 Months
Change in Tissue Doppler Diastolic Velocity
Time frame: 0-9 Months
Change in Left Ventricular Mass
Time frame: 0-9 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17138229Leichman 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.
- Results publication: PubMed 16895880Leichman 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.
- Results publication: PubMed 18954843Leichman 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.
- Results publication: PubMed 19375553Trakhtenbroit 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.
- Results publication: PubMed 20394883Taegtmeyer 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.
- Results publication: PubMed 16598541Leichman 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.
- Results publication: PubMed 19356463Taegtmeyer 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.
- Results publication: PubMed 20111021Burgmaier 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.
- Results publication: PubMed 20093477Harmancey 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.
- Results publication: PubMed 20569762Algahim 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.
- Results publication: PubMed 20676734Ballal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinrich Taegtmeyer, MD, DPhil principal investigator
University of Texas, Health Sciences Center Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 0 to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178633, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.