Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus : Natural History of Type 2 Diabetes Mellitus in Children and Young Adults

Background:Type 2 diabetes mellitus (T2DM) is a condition characterized by insulin resistance and progressive failure of the insulin-secreting beta-cells. Previously considered a disease of adults, it is now becoming increasingly prevalent in children and adolescents. Patients with childhood onset T2DM are at very high risk for diabetes-related morbidity and mortality, due to a longer life-time duration of diabetes, as well as possible increased rapidity of Beta-cell failure.Aims:In this study, we will address the following aims:To characterize hormonal, metabolic, and behavioral traits in patients with youth-onset type 2 diabetes. These will include:Assessment of Beta-cell function and insulin resistancePsychological, demographic, and socioeconomic assessmentsAssessment of the physiology and pathophysiology of incretins and other gut hormonesIdentification of early biomarkers of diabetes complications, especially cardiovascular diseaseValidation of new methods for studying glucose metabolismTo serve as a recruitment and development tool for hypothesis-driven pilot studies, discussed in the appendices of this protocol.Methods:Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner. Two control groups without diabetes will be studied for comparison purposes: healthy lean controls, and overweight/obese controls. Methods used to study participants include routine blood sampling, oral glucose tolerance testing, mixed meal testing, arginine stimulation testing, DEXA, MRI, carotid ultrasound, questionnaires, exercise physiology, and measurements of energy expenditure. Patients with type 1 diabetes will be studied using oral glucose tolerance and mixed meal tests in a pilot study of artificial sweeteners..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 16. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Diabetes Mellitus Diabetes Mellitus, Type 2 Overweight Recruitment Status: Completed Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: March 9, 2007, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024

Study ID:

NCT00445627 070115 07-DK-0115

Veröffentlichungen zur Studie:

Dabelea D, Hanson RL, Bennett PH, Roumain J, Knowler WC, Pettitt DJ. Increasing prevalence of Type II diabetes in American Indian children. Diabetologia. 1998 Aug;41(8):904-10. doi: 10.1007/s001250051006. Fridlyand LE, Philipson LH. Does the glucose-dependent insulin secretion mechanism itself cause oxidative stress in pancreatic beta-cells? Diabetes. 2004 Aug;53(8):1942-8. doi: 10.2337/diabetes.53.8.1942. Gungor N, Bacha F, Saad R, Janosky J, Arslanian S. Youth type 2 diabetes: insulin resistance, beta-cell failure, or both? Diabetes Care. 2005 Mar;28(3):638-44. doi: 10.2337/diacare.28.3.638.

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PPN (Katalog-ID):	CTG00037900X