The Effect of Acarbose on HBA1C and Lipid Profile in Patients with Metabolic Syndrome in Tertiary Care Hospital of North India
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Change in HbA1C, triglycerides, HDL and non HDL C level, and percentage of patients meeting metabolic syndrome criteria reversal after the use of Acarbose
研究概览
简要总结
This study aims to evaluate the effect of Acarbose on HbA1C and lipid profile in patients with metabolic syndrome in a tertiary care hospital in North India. Metabolic syndrome is a cluster of risk factors including abdominal obesity, insulin resistance, hypertension, dyslipidemia and impaired glucose metabolism, all of which increase the risk of type 2 diabetes and cardiovascular disease. Acarbose, an alpha glucosidase inhibitor, lowers postprandial hyperglycemia by delaying carbohydrate absorption and has also shown potential benefits in improving triglyceride and lipid levels. The primary objective is to assess changes in HbA1C, triglycerides, and non HDL cholesterol after 12 weeks of acarbose therapy, along with reversal of metabolic syndrome criteria. This randomized controlled trial will be conducted over 12 weeks on 274 patients at GSVM Medical College, Kanpur, between october 2025 and march 2026. Eligible participants are adults aged 30 to 65 years who meet at least three criteria for metabolic syndrome, either newly diagnosed or on stable oral antidiabetic agent with or without a single antihypertensive. Patients with hepatic disease, gastrointestinal disorders, severe renal impairment, insulin therapy, pregnancy, lactation, or recent acarbose use will be excluded. Participants will be divided into two groups that is Group A will receive acarbose and the standard of care, and Group B will receive only the standard of care. Baseline and follow-up assessments will include waist circumference, BMI, blood pressure, HbA1c, and lipid profile. Data will be analyzed using SPSS software, with statistical significance set at p less than 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •newly diagnosed metabolic syndrome patient or patient taking oral anti diabetic agent or anti hypertensive drug Able to attend follow up visit Willing to give informed consent.
排除标准
- •Allergy to Acarbose Hepatic dysfunction or liver cirrhosis Chronic intestinal disease related with digestive or absorption disorder Intestinal obstruction Intestinal ulcer, inflammatory intestinal disease Severe renal impairment creatinine clearance less than 60 mL per min Current or recent less than 3 months use of Acarbose Currently on insulin therapy Pregnancy or lactation.
结局指标
主要结局
Change in HbA1C, triglycerides, HDL and non HDL C level, and percentage of patients meeting metabolic syndrome criteria reversal after the use of Acarbose
时间窗: base line and 12 weeks
次要结局
- Changes in triglyceride, HDL, Non HDL C, Fasting blood glucose, ASL ALT levels after the use of Acarbose drug(base line 12 weeks)
研究者
Harshad Sahu
KPS institute of medicine, GSVM medical college, Kanpur