NCT00841009

Brief Summary

Obesity affects more than 43 million Americans and is associated with an increased incidence of heart failure, sudden death, and cardiovascular death. We have shown that increasing obesity is independently associated with potentially detrimental LV structural and functional, and metabolic changes. Thus in order to increase our understanding of the effect of obesity on the heart, we wish to study the effect of significant weight loss on these parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

6.8 years

First QC Date

February 10, 2009

Last Update Submit

May 3, 2016

Conditions

ObesityGastric Bypass

Keywords

gastric bypassobesity

Outcome Measures

Primary Outcomes (1)

  • measure the effect of marked weight loss induced by gastric bypass surgery on myocardial metabolism, efficiency, structure, and function in morbidly obese men and women

    measure at year 5

Secondary Outcomes (1)

  • evaluate the relationship between changes in myocardial lipid metabolism with changes in whole-body lipid metabolism caused by weight loss

    measure at year 5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who are to undergo gastric bypass surgery

You may qualify if:

  • Subjects that will undergo gastric bypass surgery will be included in the study.

You may not qualify if:

  • Subjects who have a history of insulin-requiring diabetes, ≥Class II hypertension, cardiac disease, major systemic disease, of smoking cigarettes with in the last 12 months, who are pregnant or taking vasoactive or lipid-lowering medications will be excluded because these conditions may affect our cardiac endpoints. Subjects unable to give informed consent will be excluded. Subjects \> 350# (the weight limit of the PET table) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

  • Bergman RN, Ider YZ, Bowden CR, Cobelli C. Quantitative estimation of insulin sensitivity. Am J Physiol. 1979 Jun;236(6):E667-77. doi: 10.1152/ajpendo.1979.236.6.E667.

    PMID: 443421BACKGROUND

  • Pacini G, Bergman RN. MINMOD: a computer program to calculate insulin sensitivity and pancreatic responsivity from the frequently sampled intravenous glucose tolerance test. Comput Methods Programs Biomed. 1986 Oct;23(2):113-22. doi: 10.1016/0169-2607(86)90106-9.

    PMID: 3640682BACKGROUND

  • Young ME, Razeghi P, Cedars AM, Guthrie PH, Taegtmeyer H. Intrinsic diurnal variations in cardiac metabolism and contractile function. Circ Res. 2001 Dec 7;89(12):1199-208. doi: 10.1161/hh2401.100741.

    PMID: 11739286BACKGROUND

  • Kates AM, Herrero P, Dence C, Soto P, Srinivasan M, Delano DG, Ehsani A, Gropler RJ. Impact of aging on substrate metabolism by the human heart. J Am Coll Cardiol. 2003 Jan 15;41(2):293-9. doi: 10.1016/s0735-1097(02)02714-6.

    PMID: 12535825BACKGROUND

  • Bergmann SR, Herrero P, Markham J, Weinheimer CJ, Walsh MN. Noninvasive quantitation of myocardial blood flow in human subjects with oxygen-15-labeled water and positron emission tomography. J Am Coll Cardiol. 1989 Sep;14(3):639-52. doi: 10.1016/0735-1097(89)90105-8.

    PMID: 2788669BACKGROUND

  • Herrero P, Markham J, Bergmann SR. Quantitation of myocardial blood flow with H2 15O and positron emission tomography: assessment and error analysis of a mathematical approach. J Comput Assist Tomogr. 1989 Sep-Oct;13(5):862-73. doi: 10.1097/00004728-198909000-00021.

    PMID: 2789240BACKGROUND

  • Herrero P, Hartman JJ, Senneff MJ, Bergmann SR. Effects of time discrepancies between input and myocardial time-activity curves on estimates of regional myocardial perfusion with PET. J Nucl Med. 1994 Apr;35(4):558-66.

    PMID: 8151375BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

2 tubes of blood (1 tablespoon total) will be collected (with permission), tested and stored for a length of time

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Linda Peterson, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

July 1, 2005

Primary Completion

May 1, 2012

Study Completion

June 1, 2014

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

US(1)