NCT00536250|CompletedDMC
Loading search results
Sponsor study identifier
Secondary identifiers
NIH
observational
255
1 country
1
Study Start
September 2001
Actual (reported)Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)The purpose of the study is to determine the role of beta-cell function and insulin resistance in the development of impaired glucose tolerance (IGT) and type 2 diabetes in children and adolescents who have an increased risk of developing type 2 diabetes due to overweight/obesity or a family history of overweight/obesity, diabetes and/or impaired fasting glucose. It is hypothesized that: 1)Obese adolescents with IGT will be more insulin resistant than obese adolescents with NGT. Insulin resistance will be the best predictor of changes in glucose tolerance status., 2)Beta cell function will be impaired in obese adolescents with IGT compared to obese adolescents with NGT., 3)Obese adolescents with IGT will present with greater intramyocellular, intrahepatic and visceral fat than obese adolescents with NGT. Furthermore, obese adolescents with IGT will have larger adipocytes, while having significantly fewer adipocytes compared to obese adolescents with NGT. Obese adolescents with IGT will also have altered expression of key genes related to insulin resistance., and 4)Abnormalities in endothelial function as manifested by low FMD and PAT are already present in obese adolescents with IGT and are linked to insulin resistance.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
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.
September 2001
Actual (reported)September 25, 2007
Actual (reported)September 27, 2007
Actual (reported)March 2017
Actual (reported)March 2017
Actual (reported)glucose tolerance
glucose tolerance status as determined by oral glucose tolerance test - fasting and 2 hour glucoses
baseline and follow up
insulin resistance
insulin resistance as measured during oral glucose tolerance test by WBISI
baseline and follow up
hepatic fat content and abdominal fat ratio
hepatic fat content and abdominal fat ratio measured by liver mri and abdominal mri
baseline and follow up
Children and Adolscents seen at the Yale Pediatric Obesity Clinic.
47 College Street
New Haven, Connecticut, 06520, United States
Berry D, Savoye M, Melkus G, Grey M. An intervention for multiethnic obese parents and overweight children. Appl Nurs Res. 2007 May;20(2):63-71. doi: 10.1016/j.apnr.2006.01.007.
McCartney CR, Blank SK, Prendergast KA, Chhabra S, Eagleson CA, Helm KD, Yoo R, Chang RJ, Foster CM, Caprio S, Marshall JC. Obesity and sex steroid changes across puberty: evidence for marked hyperandrogenemia in pre- and early pubertal obese girls. J Clin Endocrinol Metab. 2007 Feb;92(2):430-6. doi: 10.1210/jc.2006-2002. Epub 2006 Nov 21.
Sonia Caprio, M.D.
Yale University
255 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2007
First Posted
September 27, 2007
Study Start
September 2001
Actual (reported)The Metabolic Effects of Almond Consumption in Adults With Pre-Diabetes
Contact the study team to confirm eligibility.
Halloun R, Galderisi A, Caprio S, Weiss R. Adipose Tissue Insulin Resistance Is Not Associated With Changes in the Degree of Obesity in Children and Adolescents. J Clin Endocrinol Metab. 2023 Apr 13;108(5):1053-1060. doi: 10.1210/clinem/dgac700.
Trico D, Prinsen H, Giannini C, de Graaf R, Juchem C, Li F, Caprio S, Santoro N, Herzog RI. Elevated alpha-Hydroxybutyrate and Branched-Chain Amino Acid Levels Predict Deterioration of Glycemic Control in Adolescents. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2473-2481. doi: 10.1210/jc.2017-00475.
D'Adamo E, Northrup V, Weiss R, Santoro N, Pierpont B, Savoye M, O'Malley G, Caprio S. Ethnic differences in lipoprotein subclasses in obese adolescents: importance of liver and intraabdominal fat accretion. Am J Clin Nutr. 2010 Sep;92(3):500-8. doi: 10.3945/ajcn.2010.29270. Epub 2010 Jun 23.
Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
January 18, 2018
Record last verified: 2018-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: