Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Evaluation of cognitive decline
研究概览
简要总结
This study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI) documented at mini mental state examination (MMSE).
In this prospective study, 60 diabetic elderly people were enrolled and divided according to their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c <7.5%, n=30) treated with metformin, and Group B (HbA1c >7.5%, n=30) treated with metformin plus vildagliptin. We evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >65 years
- •MMSE score ≥18 and ≤23
- •diagnosis of diabetes mellitus
排除标准
- •heart failure
- •coronary heart disease
- •chronic kidney disease (G3 grade KDOQI)
- •liver cirrhosis
- •chronic respiratory failure
- •depression evaluated by Geriatric Depression (GDS, GDS >15)
- •diagnosis of dementia based on DSM 5 criteria
- •anticholinesterase or memantine therapy
研究组 & 干预措施
Metformin
metformin 1 g twice a day for 24 weeks
干预措施: Metformin Pill (Drug)
Metformin plus vildagliptin
metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
干预措施: Vildagliptin 50 MG Oral Tablet (Drug)
Metformin plus vildagliptin
metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks
干预措施: Metformin Pill (Drug)
结局指标
主要结局
Evaluation of cognitive decline
时间窗: 24 weeks
Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI).
次要结局
- Rate of Glycated hemoglobin (%)(24 weeks)
研究者
Enzo Saretto Dante Vicari
Associate Professor
University of Catania