Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks
研究概览
简要总结
The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.
详细描述
The study assessed and estimated the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks.
The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Single blind study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •Hba1c 7-11%,
- •Renal function (MDRD) > 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, or basal insulin} at a stable dose for at least 3 months.
排除标准
- •Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).
- •Diabetes other than type 2 diabetes
- •Age younger than 18 years.
- •Pregnant patients or lactating.
- •Patients who refuse to give consent to be enrolled in the study.
- •Any contraindication to magnetic resonance imaging.
- •More than 5% total body weight loss within the last month.
- •Patients with moderate or severe renal impairment
- •Any contraindication to SGLT2i
- •Prior SGLT2i within the past 3 months
研究组 & 干预措施
Dapagliflozin group
The patients were given standard drugs for type 2 diabetes and Dapagliflozin.
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
To assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks
时间窗: 24 weeks
The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a change will be compared
次要结局
- To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)(24 weeks)
研究者
Ashu Rastogi
Associate professor, Department of endocrinology and metabolism , PGIMER chandigarh
Post Graduate Institute of Medical Education and Research, Chandigarh