Efficacy of Diet in Elderly With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Handgrip test
研究概览
简要总结
Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.
This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be introduced to a targeted nutritional program aimed at improving the composition of the diet, in terms of both micro- and macro-nutrients.
详细描述
The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who receive the nutritional program. Particular attention will be paid to the intake of an adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required to assess daily protein-calorie intake and questionnaires to assess daily physical activity and quality of life.
The primary objective is to assess the efficacy of nutritional intervention in elderly affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to non-diabetic subjects and to verify the relationship between pharmacological therapy and the presence of sarcopenia as well as evaluate any changes in style and quality of life and of glycometabolic compensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •BMI >20 kg/m2
- •HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)
排除标准
- •T1DM or LADA
- •Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system
研究组 & 干预措施
Sarcopenic
subjects with sarcopenia diagnosis
干预措施: mediterranean diet with adequate protein intake (Dietary Supplement)
Non sarcopenic
subjects without sarcopenia diagnosis
干预措施: mediterranean diet with adequate protein intake (Dietary Supplement)
结局指标
主要结局
Handgrip test
时间窗: 1 years
Increase of hand grip strength (units: kg)
次要结局
- Glycemic control(1 year)
- Dietary lifestyle(1 year)
- Anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS(1 year)
研究者
Emanuela Orsi
medical doctor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico