Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prevalence of sarcopenia
研究概览
简要总结
Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 years, both sexes
- •Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII)
- •Informed consent before any study activity
- •Ability to fully perform all protocol activities
排除标准
- •Previous diagnosis of T2DM
- •Previous diagnosis of dementia
- •Presence of heart failure (NYHA class III and IV)
- •Presence of muscular disease
- •Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
- •eGFR evaluated through CKD-EPI formula <20 ml/min /1.73m2 , estimated on previous creatinine dosage
- •Previous history of stroke or cerebrovascular disease
- •Diagnosis of coeliac disease
- •Diagnosis of chronic inflammatory bowel disease
- •Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH >5 or TSH <0.15)
- •Alcohol abuse or consumption of more than 14 alcoholic units weekly
- •Active cancer or therapy
- •Primary hyperparathyroidism
- •Corticosteroid and/or estrogen-progestogen therapy for at least 12 months in medical history
- •On going treatment with antiretroviral therapy
- •On going treatment with immunosuppressive therapy, e.g. cyclosporine, tacrolimus
- •On going treatment with anti-epileptic drugs
研究组 & 干预措施
Type 1 Diabetes
Subjects with type 1 diabetes who will be evaluated for sarcopenia, evaluating body composition through DEXA and muscular strength by handgrip.
干预措施: Dual energy X-ray absorptiometry (Procedure)
结局指标
主要结局
Prevalence of sarcopenia
时间窗: through study completion, an average of 1 year
Prevalence of sarcopenia in adult population with T1DM. Sarcopenia will be defined according to the 2018 European Working Group on Sarcopenia in Older People (EWGSOP) guidelines
次要结局
- Prevalence of microvascular complications in subjects with T1DM and sarcopenia(through study completion, an average of 1 year)
- Prevalence of dynapenia(through study completion, an average of 1 year)