DRKS00013501尚未招募未知
Metabolic and neurovascular brain plasticity in amyloid-positive older people with metabolic risk factors - EnergI
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 65 Years 至 75 Years(—)
- 性别
- All
入选标准
- •Body Mass Index = 25 to max. 40 kg / m2
- •- Presence of at least one metabolic risk factor (according to ATP III criteria (National Cholesterol Education Program (NCEP): Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III Final Report), 2002 )
- •Abdominal obesity, determined by a waist circumference of over 102 cm in men or over 88 cm in women
- •Fasting triglycerides greater than 150 mg/dl (> 1.7 mmol/l), or already initiated therapy to reduce triglycerides
- •HDL cholesterol = 40 mg/dl (<1.05 mmol/l) in men or <50 mg/dl (1.25 mmol/l) in women
- •Blood pressure of 130/85 mmHg or higher, or already initiated therapy to reduce hypertension
- •Fasting glucose = 110 mg/dl (5.6 mmol/l)
- •- Written declaration of consent for PET measurements with [18F]-FDG and [18F]-Florbetaben
- •- Preserved legal capacity of the subjects at the time of each examination
排除标准
- •- Coronary heart disease in all manifestations
- •- Cardiomyopathies
- •- Supraventricular and ventricular arrhythmias
- •- Clinically relevant cardiac defects
- •- Blood pressure above 140/90 mmHg
- •- heart insufficiency > stage IIb according to NYHA
- •- Severe chronic obstructive pulmonary disease (COPD), bronchial asthma
- •- Resting bradycardia (below 45 bpm)
- •- Relevant orthopedic diseases
- •- Serious internal diseases
- •- MRI disqualification(claustrophobia, pacemakers, metallic endoprostheses)
- •- Severe vision or hearing impairments (uncorrected)
- •- Body mass index >40 or <25 kg/m2
- •- Current major depressive disorder and / or severe neuropsychological disorder
- •- Current severe neurological disease of the central nervous system
- •- Current dependence (e.g. alcohol, psychoactive pharmaceuticals, cocaine, heroin)
- •- Acute viral or bacterial infection
- •- Intake of antidiabetics
- •- Diabetes mellitus
- •- Regular intake of benzodiazepines
- •- Incapable of doing sports
- •- Foot deformities of any kind
- •- Persons for whom radioactive substances or ionizing radiation have been used for research or treatment purposes in the past ten years (§88 (2) Radiation Protection Ordinance), excluding purely diagnostic examinations
- •- Serious liver disease (e.g. chronic hepatitis, cirrhosis of the liver) or renal dysfunction requiring dialysis
- •- History of stroke or epilepsy
研究者
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