NCT01508598|Terminated
Study Stopped
Not enough subjects enrolled to be able to analyze data.
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Not enough subjects enrolled to be able to analyze data.
Sponsor study identifier
observational
390
1 country
1
Study Start
February 2012
Actual (reported)Primary Completion
January 2, 2018
Actual (reported)Study Completion
January 2, 2018
Actual (reported)Identification and validation of early chronic disease biomarkers in children is of paramount importance especially in the burgeoning arena of pediatric obesity research. Despite the presence of risk factors, few obese children develop overt cardiovascular disease (CVD) early in life. However, because CVD is a cumulative process occurring over time, identifying the earliest signs in order to intervene sooner may have a large impact on slowing its progression. Endothelial activation is one of the earliest detectable signs of the beginnings of CVD. However, accurately quantifying endothelial health in children has proven to be a major challenge. Direct measures of endothelial cell biology, such as circulating endothelial cells (CEC) and endothelial microparticles (EMP), have been extensively studied in adults and are associated with vascular diseases, CVD risk factors, and CVD events. Despite being well-validated in adults, CEC and EMP have not been formally evaluated as disease biomarkers in children and adolescents. Pediatric obesity is an ideal condition in which to validate CEC and EMP as disease biomarkers since adiposity in childhood is associated with CVD, type 2 diabetes mellitus, and premature death, later in life. The investigators primary focus in this study will be the evaluation of CEC and EMP as biomarkers of CVD risk and whether substantial changes in weight affect these biomarkers. The investigators propose to evaluate the change in levels of CEC and EMP in response to substantial weight loss in 32 adolescents with extreme obesity undergoing elective, clinically-indicated bariatric surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2011
Actual (reported)January 12, 2012
Actual (reported)February 2012
Actual (reported)January 2, 2018
Actual (reported)January 2, 2018
Actual (reported)Change from Baseline in Circulating Endothelial Cell (CEC) VCAM Expression at 12-months
Baseline and 12-months
Change from Baseline in Circulating Endothelial Cell (CEC) Enumeration at 12-months
Baseline and 12 Months
Change from Baseline in Endothelial Microparticle (EMP) VCAM Expression at 12-months
Baseline and 12 Months
Change from Baseline in Endothelial Microparticle (EMP) Enumeration at 12-months
Baseline and 12 Months
Change from Baseline in Circulating Endothelial Cell (CEC) VCAM Expression at 6-months
Baseline and 6-Months
Change from Baseline in Circulating Endothelial Cell (CEC) Enumeration at 6-months
Baseline and 6-Months
Thirty-two children and adolescents, who are currently scheduled to undergo elective bariatric surgery.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Fox CK, Northrop EF, Rudser KD, Ryder JR, Kelly AS, Bensignor MO, Bomberg EM, Bramante CT, Gross AC. Contribution of Hedonic Hunger and Binge Eating to Childhood Obesity. Child Obes. 2021 Jun;17(4):257-262. doi: 10.1089/chi.2020.0177.
Fyfe-Johnson AL, Ryder JR, Alonso A, MacLehose RF, Rudser KD, Fox CK, Gross AC, Kelly AS. Ideal Cardiovascular Health and Adiposity: Implications in Youth. J Am Heart Assoc. 2018 Apr 13;7(8):e007467. doi: 10.1161/JAHA.117.007467.
10 mL of blood serum and 5 mL of blood plasma will be frozen in long-term storage for future study analyses and use. 8 mL of urine will be frozen in long-term storage for future study analyses and use.
Aaron S Kelly, Ph.D.
University of Minnesota
390 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2011
First Posted
January 12, 2012
Study Start
February 2012
Actual (reported)Starting Early Obesity Prevention Program
Contact the study team to confirm eligibility.
Primary Completion
January 2, 2018
Actual (reported)Study Completion
January 2, 2018
Actual (reported)Last Updated
August 24, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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