Anti-inflammatory Small Drug as Adjunctive Therapy to Improve Glucometabolic Variables in Obese, Insulin-Resistant Type 2 Diabetic Patients

抗炎小药作为辅助治疗可改善肥胖、胰岛素抵抗 2 型糖尿病患者的糖代谢变量

• 批准号: 8996344
• 负责人: Nick Giannoukakis
• 金额: $ 116.34万
• 依托单位: ALLEGHENY-SINGER RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-15 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8996344
• 关键词: Adverse effects; Adverse event; Anti-Inflammatory Agents; Anti-inflammatory; Attenuated; Autoimmune Diabetes; Autoimmunity; B-Lymphocytes; Beta Cell; Biological Preservation; Blood - brain barrier anatomy; Body Weight; C-Peptide; C-reactive protein; Caring; Cell Count; Cell physiology; Cellular Immunity; Chronic; Clinical; Clinical Trials; Data; Dendritic Cells; Desmosine; Diabetes Mellitus; Disease; Dose; Double-Blind Method; Elastases; Enzyme Inhibitor Drugs; Enzyme Inhibitors; Euglycemic Clamping; Fibrinogen; Flow Cytometry; Frequencies; Gap Junctions; Gene Expression; Gene Expression Profile; Gene Expression Profiling; Glucose; Glucose Clamp; Glycosylated hemoglobin A; Health; Health Care Costs; Hip region structure; Human; Hypoglycemia; Immune; Impairment; Incidence; Individual; Inflammation; Inflammatory; Insulin Resistance; Interleukin-6; Knowledge; Leukocyte Elastase; Leukocytes; Lipids; Maintenance; Measures; Metabolic; Metabolic Control; Metabolism; Methods; Natural Immunity; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Obesity; Outcome; Patients; Peripheral; Pharmaceutical Preparations; Phase II Clinical Trials; Phenotype; Placebo Control; Placebos; Plasma; Polymerase Chain Reaction; Population; RNA; Randomized; Residual state; Risk Factors; Role; Safety; Severities; Structure of beta Cell of islet; Study Subject; T-Lymphocyte; Testing; Therapeutic; Time; Tumor Necrosis Factor-alpha; Urine; alpha 1-Antitrypsin; attenuation; base; blood glucose regulation; design; diabetes mellitus therapy; diabetic; diabetic patient; disorder risk; efficacy testing; fasting plasma glucose; glucose monitor; glycemic control; high risk; human TNF protein; improved; in vitro activity; in vivo; innovation; insulin secretion; insulin sensitivity; neutrophil; neutrophil elastase inhibitor; novel; peripheral blood; polypeptide C

 DESCRIPTION (provided by applicant): The role of individual leukocyte populations in type 2 diabetes (T2D) and immunometabolism in general represent important gaps in knowledge to better understand the etiopathogenesis of T2D. Emerging evidence indicates that certain leukocyte populations serve as an important nexus of T2D-associated inflammation. This novel and innovative clinical trial will test the efficacy of a leukocyte-selective anti-inflammatory small drug as adjunctive therapy in improving insulin sensitivity in obese, insulin-resistant type 2 diabetic subjects. This trial also offers a first-in-kind opportunity to better understand the role of specific leukocyte populations in type 2 diabetes. The drug’s clinical profile suggests that it will be well-tolerated with few, if any, side effects, and the existence of simple methods that can indirectly measure its activity in vivo.

 描述（由申请人提供）：个体白细胞群在 2 型糖尿病 (T2D) 和免疫代谢中的作用总体上代表了更好地理解 T2D 发病机制的重要知识空白。新出现的证据表明，某些白细胞群是 2 型糖尿病的重要联系。这项新颖且创新的临床试验将测试白细胞选择性抗炎小药作为辅助治疗在改善胰岛素敏感性方面的功效。该试验还为肥胖、胰岛素抵抗的 2 型糖尿病受试者提供了首次机会，以更好地了解特定白细胞群在 2 型糖尿病中的作用。如果有的话，副作用，以及是否存在可以间接测量其体内活性的简单方法。