Therapeutic targets in African-American youth with type 2 diabetes

患有 2 型糖尿病的非裔美国青年的治疗目标

基本信息

批准号：
10250258
负责人：
Stephanie Therese Chung
金额：
$ 119.82万
依托单位：
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10250258
关键词：
Address Adult Affect African American Age Antidiabetic Drugs COVID-19 pandemic Child Chronic Disease Combined Modality Therapy Complication Data Diabetes Mellitus Diagnosis Disease Early treatment Enrollment Functional disorder Genes Genetic Gluconeogenesis Glucose Goals Hepatic Hormones Individual Inpatients Insulin Interruption Intervention Trial Journals Liver Manuscripts Medical History Metabolic Metformin Minority Monitor Non-Insulin-Dependent Diabetes Mellitus Oral Outcome Outpatients Participant Patient Recruitments Patients Peer Review Pharmaceutical Preparations Pharmacogenomics Physical Examination Pilot Projects Precision Medicine Initiative Prediabetes syndrome Process Protocols documentation Public Health Randomized Regimen Research Design Role Running Testing Time Treatment Failure United States National Institutes of Health Visit Work Writing Youth adolescent drug use aged clinical center design eligible participant experience follow-up glucagon-like peptide 1 glucose production glucose tolerance gut bacteria health disparity high risk improved improved outcome insight insulin sensitivity liraglutide microbiome minority children novel novel therapeutics patient screening proctolin randomized trial recruit screening stable isotope therapeutic target treatment arm

项目摘要

This is a 3-month randomized trial in youth with type 2 diabetes with 2 intervention arms (metformin alone and metformin and liraglutide). Our project has successfully recruited participants but have experienced multiple delays in protocol initiation and recruitment related to interruptions in stable isotope supply at the NIH Clinical center as well as the COVID-19 pandemic. During Fiscal Year 2019-2020, we continued enrollment until March 2020 when study recruitment across the NIH CC was abruptly halted by the COVID-19 pandemic. Study recruitment remained on hold until August 2020 and we have just begun to screen patients again. Our randomized study should be allowed to continue because our findings will provide novel insight into pathophysiology of diabetes in youth, the drugs used to treat this chronic disease and pharmacogenomic targets. Despite these delays, the exploratory outcomes and findings are intriguing. Our manuscript entitled Metformin Increases GLP-1 Concentrations and Improves Glycemia in Youth with Type 2 Diabetes was accepted into Diabetologia Journal after extensive peer review. We have also generated pilot data for the role of microbiome in metformin treated youth and are in the process of writing a new protocol for this aim.

这是一个3个月的随机试验，该试验在2型糖尿病的年轻人中具有2个干预臂（单独二甲双胍，二甲双胍和liraglutide）。我们的项目已成功招募参与者，但在NIH临床中心以及COVID-19-19的大流行方面的稳定同位素供应中断相关的协议启动和招聘方面经历了多次延迟。在2019-2020财政年度期间，我们继续入学到2020年3月，当时NIH CC的研究招募被19CON COVID-19的大流行暂停。研究招聘一直持续到2020年8月，我们才刚刚开始再次筛查患者。我们的随机研究应继续进行，因为我们的发现将提供对青年糖尿病病理生理学的新洞察力，用于治疗这种慢性疾病和药物基因组靶标的药物。尽管有这些延误，但探索结果和发现还是令人着迷的。在广泛的同行评审之后，我们的手稿标题为“二甲双胍增加了GLP-1浓度，并改善了2型糖尿病青年的血糖量。我们还为微生物组在二甲双胍治疗的青年中的作用生成了试点数据，并正在为此目标编写新协议。