Effects of an Exercise Program on Physical Functionality and Frailty in Type 2 Diabetic Older Adults. Role of Circulating Concentration of PDEF and Differential Genes
试验速览
- 阶段
- 不适用
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks
研究概览
简要总结
Diabetes is a disease with a high impact in the population older than 65 years old. Some indications suggest that diabetes in the old age aggravate the negative effects of ageing, as the loss of muscle mass and strength, bringing the patients to a situation of vulnerability and elevated risk of disability and death known as "frailty syndrome". Recently, scientists have observed that if older population train with musculation machines emphasising the muscular power, it is possible to have an impact on a disminution of frailty and restoring the physical functionality. This project deeps in the physiological and molecular mechanisms that underlie to improvements in the frail diabetic patients.
详细描述
It is hypothesised that:
- High intensity training (strength-power) prescribed properly in an individualised form and supervised could influence significantly on the phenotypic response in the DM type 2: decreasing the level of clinical severity, disability and frailty, improving quality of life and glycaemic control, functional capacity and body composition (especially the muscle mass) of the diabetic patients (type 2) older than 65 years old.
- Part of the training adaptations in diabetic patients (type 2) older than 65 years old could due to physiological conditions as the systemic level of biomarkers as PDEF in these patients.
- Part of the training adaptations in diabetic patients (type 2) could be influenced by the characterisation of associated genes to the different types of DM type 2 recently characterised.
The principal aims are:
- To evaluate the effectiveness of a novel intervention based on strength-power exercise in individuals older than 65 years old with DM type 2 and frailty in term of: level of clinical severity, disability, glycaemic control, quality of life, functional capacity, state of frailty and body composition.
- To establish whether PDEF serves as diagnostic and prediction biomarker to training response, providing an objective and accessible method that would stratify the response to the intervention helping with the patients screening.
- To determine the role of characterised genetic variants in the different subgroups of DM type 2 in the level of response to the training stimuli.
Study design Longitudinal intervention stratified study, controlled and single-blinded, with a group of intervention and control group.
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an informed consent.
- •Older than 65 years old with Type 2 Diabetes Mellitus diagnosed in a minimum of 2 previous years.
- •Being diagnosed frail, pre-frail or no frail.
排除标准
- •Barthel's index lower than 60 points.
- •Incapacity to complete the SPPB fitness test.
- •Score lower than 20 points in the Mini Mental State Examination.
- •Cardiovascular event in the previous 6 months following the New York Heart Association (NYHA) classification.
- •Patients clinically unstable by the investigator's judgement.
- •Terminal disease (life expectancy lower than 6 months).
- •Participation in another study that could interfere in the results of the current research.
研究组 & 干预措施
Power training group
Participants will be enrolled in a resistance training program.
干预措施: Power resistance training (Other)
Control group
Participants will be doing their normal life.
结局指标
主要结局
Change from Baseline Glycosylated Hemoglobin (Hemoglobin A1c) at 12 weeks
时间窗: 0 and 12 weeks.
Percentage
Change from Baseline Homeostasis Model Assessment - Beta cells (HOMA2-B) at 12 weeks
时间窗: 0 and 12 weeks.
Percentage
Change from Baseline Levels of strength at 6 and 12 weeks
时间窗: 0, 6 and 12 weeks.
Load (kg).
Change from Baseline Bone Mineral Density at 12 weeks
时间窗: 0 and 12 weeks.
g/cm3
Change from Baseline Homeostasis Model Assessment - Insuline Resistance (HOMA2-IR) at 12 weeks
时间窗: 0 and 12 weeks.
Percentage
Change from Baseline Disability at 6 and 12 weeks
时间窗: 0, 6 and 12 weeks.
Level of disability assessed by the Barthel test. A participant scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Change from Baseline Fried frailty score at 6 and 12 weeks
时间窗: 0, 6 and 12 weeks.
Level of frailty assessed by Fried Criteria. Intermediate or prefrail: 1 or 2 criteria present. Positive for frailty phenotype: ≥3 criteria present.
Change from Baseline Functional capacity at 6 and 12 weeks
时间窗: 0, 6 and 12 weeks.
Level of functional capacity assessed by the test SPPB. Scores 0-3: Very low physical function; Scores 4-6: Low physical function; Scores 7-9: Moderate physical function; Scores 10-12: High physical function
Genotyping of HLA (rs2854275)
时间窗: 0 week.
Assessed by Real-time PCR.
Functional mobility at 6 and 12 weeks
时间窗: 0, 6 and 12 weeks.
Level of functional mobility assessed by the Lawton test. A scale from 0 to 8, expressing higher scores better levels of independence.
Change from Baseline Muscular power at 6 and 12 weeks
时间窗: 0, 6 and 12 weeks.
Watts.
Genotyping of TM6SF2 (rs10401969)
时间窗: 0 week.
Assessed by Real-time PCR.
Genotyping of TCF7L2 (rs7903146)
时间窗: 0 week.
Assessed by Real-time PCR.
Change from Baseline Pigment Epitelium Derived Factor (PEDF) at 12 weeks
时间窗: 0 and 12 weeks.
Circulating level of PDEF assessed by Western Blot.
次要结局
- Change from Baseline Subjective level of quality of life at 12 weeks(0 and 12 weeks.)
- Change from Baseline Balance at 12 weeks(0 and 12 weeks.)
- Change from Baseline Body Mass Index at 6 and 12 weeks(0, 6 and 12 weeks.)
- Change from Baseline Blood pressure (systolic and diastolic) at 6 and 12 weeks(0, 6 and 12 weeks.)
- Change from Baseline Concentration of Total Cholesterol at 12 weeks(0 and 12 weeks.)
- Change from Baseline Concentration of HDL Cholesterol at 12 weeks(0 and 12 weeks.)
- Change from Baseline Concentration of LDL Cholesterol at 12 weeks(0 and 12 weeks.)
- Change from Baseline Physical activity at 12 weeks(0 and 12 weeks.)
- Change from Baseline Waist circumference at 6 and 12 weeks(0, 6 and 12 weeks.)
- Change from Baseline Concentration of Triglycerides at 12 weeks(0 and 12 weeks.)
研究者
Amelia Guadalupe Grau
Principal Investigator
Technical University of Madrid