Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes of cognitive function assessed by cognitive function scale
研究概览
简要总结
Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied.
Sodium-glucose transporter-2 (SGLT-2) inhibitors, which lower serum glucose by inhibiting SGLT2-mediated glucose reabsorption in renal proximal tubules, could be neuroprotective. It was recently reported that the SGLT-2 inhibitor improved cognitive function and ameliorated oxidative stress via attenuating mitochondrial dysfunction, insulin resistance, inflammation, and apoptosis in mice or HFD-induced obese rats, that means SGLT-2 inhibitor may provide neuroprotection in the diabetic brain. Hence, Invokana (Canagliflozin) might act as a potent dual inhibitor of AChE and SGLT2. Since the development of diabetes is associated with AD, the design of new AChE inhibitors based on antidiabetic drug scaffolds would be particularly beneficial. Moreover, the present computational study reveals that Invokana (Canagliflozin) is expected to form the basis of a future dual therapy against diabetes associated neurological disorders.
The overall goal of this study is to explore the effects of SGLT2 inhibitor on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.
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
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly onset type 2 diabetes within 3 months
- •7%<HbA1c<10%
排除标准
- •Type 2 diabetes with acute diabetic complications.
- •Type1 diabetes.
- •Thyroid dysfuncition.
- •Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- •History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- •Hepatic insufficiency (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- •Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- •Acute infections, tumor, severe arrhythmia.
- •Alcohol or medicine addiction, psychoactive substance abuse.
- •Other diseases affecting cognitive function (congenital dementia, brain trauma, parkinson's diseases, toxicencephacopathy,epilepsy, mental disorders, severe lungdy sfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.)
- •Fertile woman without contraceptives.
- •Allergic to or have contraindication to the intervention drugs.
研究组 & 干预措施
Canagliflozin
12 weeks of Canagliflozin(100mg/day) treatment, randomly
干预措施: Canagliflozin (Drug)
Sitagliptin
12 weeks of Sitagliptin (100mg/day) treatment, randomly
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Changes of cognitive function assessed by cognitive function scale
时间窗: 12 weeks
cognitive function scale
次要结局
- Changes of standardized uptake values of brain and splanchnic organs assessed by 18F-PET-CT(1 week)
- Changes of brain function assessed by near infrared brain functional imaging(4 week)
- Changes of urinary sodium and glucose excretion (mmol/24h)(1 week)
研究者
Zhiming Zhu
Director of the Department of Hypertension & Endocrinology, Daping Hospital
Third Military Medical University