The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- serum amyloid-β
研究概览
简要总结
This is a single-center, randomized controlled clinical trial with a parallel-group design conducted at Minia University hospital.
详细描述
All patients admitted to Diabetes clinics of Minia University Hospital, will be screened for the eligibility criteria.
diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups.
Group I=35 T2DM patients given DPP4Is Group II=35 T2DM patients given DPP4Is and metformin. Group III=35 patients will be given placebo (only adjust their drugs to control blood glucose level)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
all patient information will be anonymized giving only corresponding numbers, which will be revealed by the PI after assessment.
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (A1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate.
排除标准
- •Those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.
研究组 & 干预措施
Control Group
35 patients will be given placebo (only adjust their drugs to control blood glucose level)
干预措施: Control group (Drug)
DPPI Group
35 T2DM patients will be given DPP4Is once or twice daily
干预措施: DPP-4 inhibitor group (Drug)
DPPI + metformin group
35 T2DM patients will be given DPP4Is + metformin once or twice daily
干预措施: DPP-4 inhibitor + metformin group (Drug)
结局指标
主要结局
serum amyloid-β
时间窗: Before and post 6 month of treatment
PHQ-9
时间窗: Before and post 6 month of treatment
Validated questionnaire assessing patient mental health and depression PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.;
Serum Inflammatory mediators; TNF-α
时间窗: Before and post 6 month of treatment
ELISA kits
MMSE score
时间窗: Before and post 6 month of treatment
Validated questionnaire assessing the Estimation of Mini Mental State The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia Examination (MMSE) score
次要结局
- Serum fasting and 2-he post prandial glucose(Before and post 6 month of treatment)
- Serum Insulin(Before and post 6 month of treatment)
- HOMA-IR(Before and post 6 month of treatment)
研究者
Asmaa Abdelfattah Elsayed
Lecturer of clinical pharmacy
Beni-Suef University