Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)
研究概览
简要总结
A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association
- •Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)
- •Healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria
- •Exclusion Criteria (overall population):
- •acute diseases,
- •chronic obstructive pulmonary disease (COPD)
- •conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer),
- •obesity (body mass index ≥30 kg/m2)
- •moderate-severe hepatic disease,
- •chronic kidney disease (estimated glomerular filtration rate <30 ml/min per 1.73m2),
- •metal prostheses,
- •recent or ongoing infection,
- •inability or unwillingness to provide informed consent
- •Exclusion Criteria (diabetic population):
- •type 1 diabetes,
- •hemoglobin A1c >8.5% (69 mmol/mol),
- •basal-bolus insulin therapy,
- •insulin pump therapy,
- •proliferative diabetic retinopathy,
- •diabetic foot.
排除标准
- 未提供
结局指标
主要结局
Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)
时间窗: 2 years
The primary objective of the study is to detect differences in inflammatory markers in the four groups
次要结局
未报告次要终点
研究者
Giaccari Andrea
MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS