Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV
研究概览
简要总结
This study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with Parkinson's disease over a 12-week period.
详细描述
This study is a single-center, parallel and double-blind study. Patients with Parkinson's disease referred to Movement Clinic of Shohada-e-Tajrish Hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks. Motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms (MDS-UPDRS; part III, IV), and secondary outcomes are motor (gait balance) and non-motor (MDS-UPDRS part I, II, cognition, depression, anxiety and fatigue) symptoms. Patients, researchers (physicians, outcome assessors) and data analysts are blinded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man and woman over 17 years old
- •Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
- •Provide written informed consent to participate in the study.
- •Understand that they may withdraw their consent at any time.
排除标准
- •Pregnant and lactating women
- •Patients with diabetes and taking anti-hyperglycemic drugs
- •Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, Amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, etc.
- •Patients who cannot walk for more than one minute without help
- •A history of allergic reaction to insulin
- •The presence of inflammation of nasal cavity that may prevents absorption of insulin
研究组 & 干预措施
Insulin
Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks
干预措施: Insulin (Drug)
Placebo
Normal saline, twice a day, intranasally, every day for 12 weeks
干预措施: Normal saline (Drug)
结局指标
主要结局
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV
时间窗: Base line, 4, 8 and 12 weeks after intervention
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, IV assess the motor signs of Parkinson's Disease; higher score means more severity of the motor symptoms.
次要结局
- Cognitive score(Base line, 4, 8 and 12 weeks after intervention)
- Disease severity(Base line, 4, 8 and 12 weeks after intervention)
- Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II(Base line, 4, 8 and 12 weeks after intervention)
- Risk of Falling(Base line, 4, 8 and 12 weeks after intervention)
- Depression score(Base line, 4, 8 and 12 weeks after intervention)
- Anxiety score(Base line, 4, 8 and 12 weeks after intervention)
- Fatigue score(Base line, 4, 8 and 12 weeks after intervention)
研究者
dr.dargahi
Associate professor
Shahid Beheshti University of Medical Sciences