NCT06191328尚未招募不适用
A Prospective, Open, Self-controlled Study of the Effects of Chiglitazar Sodium on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes Mellitus (T2DM)
Yufan Wang1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration.
The main question[s] it aims to answer are:
- Quantitative lipidomics information enables in-depth analysis of lipids and can reveal Chiglitazar Sodium-specific lipid metabolic patterns, thereby strengthening lipidomics as a promising tool for exploring the molecular mechanisms of T2DM.
- It can also be applied to other T2DM lipidomics studies to better understand lipid metabolism patterns and integration with other omics measures.
详细描述
Chiglitazar Sodium for lipid profile abnormalities and its associated effective lipid molecular biomarkers have never been studied in patients with T2DM. Therefore, our study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration using ultra-high performance liquid chromatography-Tandem quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS). For completeness, we also evaluated the effects of Chiglitazar Sodium treatment on metabolic markers associated with T2DM and its association with lipidomic changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes (T2DM) WHO meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
- •Male or female patients aged ≥18, ≤70 years;
- •BMI≥18.5 Kg/m2, < 35 Kg/m2;
- •Hemoglobin a1C (HbA1C) ≥7.5%; ≤10.5%;
- •Triglyceride ≤500 mg /dL (5.65 mmol/L) (if the researchers judge that the transient increase caused by diet, etc., can be repeated detection)
- •Total cholesterol (TC) ≤250mg/dl (6.45mmol/L)
- •T2DM patients who are taking one or two kinds of oral hypoglycemic drugs with fixed dose ≥2 months and uncontrolled blood glucose.
- •Voluntarily sign informed consent and agree to enter the trial group.
排除标准
- •Type 1 diabetes or other specific type of diabetes
- •Fasting blood glucose (FPG) > 13.3 mmol/L (240 mg/dL);
- •Triglyceride (TG) > 500 mg /dL (5.65 mmol/L);
- •Total cholesterol (TC) > 250mg/dl (> 6.45mmol/L);
- •Refractory hypertension [that is, on the basis of improving the lifestyle, the blood pressure is still not up to standard after 1 month of applying a reasonably tolerable amount of 3 or more antihypertensive drugs (including diuretics), or the blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs;
- •Taking fibrates, statins, thiazolidinediones, insulin drugs;
- •A clear diagnosis of severe osteoporosis or any other known bone disease;
- •A history of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
- •Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio > 300 mg/g; Marked peripheral neuropathy, etc.);
- •The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV;
- •Significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST> 2.5 times the upper limit of normal and/or ALT> 2.5 times the upper limit of normal and/or total bilirubin > 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR<60 ml/ (min*1.73m2));
- •Pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
- •Participating in a clinical trial of another drug or medical device in or within 3 months prior to screening;
- •The investigator considers it inappropriate to participate in this clinical trial.
研究组 & 干预措施
Intervention group
Experimental
干预措施: Chiglitazar sodium (Drug)
结局指标
主要结局
HbA1c
时间窗: 12 weeks of treatment
Change in HbA1c from baseline
次要结局
- Serum lipid profile(12 weeks of treatment)
研究者
Yufan Wang
Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
Loading locations...
相似试验
终止
不适用
Analysis of Lipid Biomarkers of Exposure and Host ResponseCigarette SmokingNCT00493831University of Nebraska24
Unknown
不适用
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.HypercholesterolemiaNCT01982461Pin Siang Medical Biotechnology Co., Ltd.40
已完成
4 期
Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received TreatmentHIVNCT00757783Tibotec, Inc68
已完成
3 期
A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)HypercholesterolemiaNCT00132717Organon and Co450
招募中
不适用
A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT05189639Pfizer165