A Cross-Sectional Study to Explore Metabolic Proteins in the PI3K/AKT and cAMP/PKA Signaling Pathways in Type 2 Diabetes Mellitus Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Serum levels of GP73, FAM3A, ASGR1, and GPHB5 measured by ELISA in Healthy, Prediabetes, and Type 2 Diabetes Mellitus groups.
研究概览
简要总结
This cross-sectional study will quantify serum GP73, GPHB5, FAM3A and ASGR1 at one baseline visit in adults classified as healthy controls, prediabetes and type 2 diabetes mellitus, and examine their relationships with glycaemic control (glycated haemoglobin and fasting plasma glucose), indices of insulin resistance and beta-cell function (HOMA IR and HOMA Beta), inflammatory markers (IL-1B, IL-10). The study hypothesis is that GP73, GPHB5 and ASGR1 are higher in prediabetes and type 2 diabetes than in healthy controls and are positively associated with poorer glycaemic control, greater insulin resistance and higher inflammatory activity, whereas FAM3A is lower and inversely associated with these parameters.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Controls Age between 18 and 65 years Both Male and Female HbA1c less than 5.7 percent based on ADA diagnostic criteria for normal glucose tolerance.
- •No history of acute or chronic infections, inflammatory diseases, or malignancy.
- •Not currently taking medications known to affect glucose metabolism, lipid profile, or inflammatory markers.
- •Willing to provide written informed consent Pre-diabetes Age between 18 and 65 years Both Male and female HbA1c between 5.7 and 6.4 percent No prior diagnosis of diabetes mellitus No ongoing antidiabetic treatment Free from chronic illnesses such as renal, hepatic, cardiac, or autoimmune diseases.
- •Willing to provide written informed consent T2DM Age between 18 and 65 years Both Male and female HbA1c equal to or more than 6.5 percent as per ADA criteria or patient taking OHAs Stable clinical condition without history of diabetic ketoacidosis, hyperosmolar hyperglycemic state, or recent hospitalization (within last 3 months).
- •Not on medications that could affect study biomarkers, except for prescribed antidiabetic drugs and routine medications for controlled comorbidities.
- •Participants willing to provide written informed consent and adhere to study protocols.
排除标准
- •Age below 18 years or above 65 years Pregnant or lactating women History of type 1 diabetes, gestational diabetes, or secondary diabetes Presence of chronic systemic illness (renal failure, advanced liver disease, heart failure, autoimmune disorders, malignancy) Acute infection or hospitalization in last three months Current use of medicines that significantly alter glucose metabolism, lipid profile, or inflammatory markers (other than prescribed oral antidiabetic drugs) Inability or unwillingness to provide informed consent.
结局指标
主要结局
Serum levels of GP73, FAM3A, ASGR1, and GPHB5 measured by ELISA in Healthy, Prediabetes, and Type 2 Diabetes Mellitus groups.
时间窗: There will be a single assessment at baseline (at the time of enrollment)
Correlation of serum GP73, FAM3A, ASGR1, and GPHB5 with key glycemic parameters (HbA1c, fasting plasma glucose).
时间窗: There will be a single assessment at baseline (at the time of enrollment)
次要结局
- Association of serum GP73, FAM3A, ASGR1, & GPHB5 with inflammatory markers (IL-1B, IL-10).
研究者
Prof Nilanjan Saha
Jamia Hamdard