Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Muscular strength
研究概览
简要总结
This is an exploratory study based on the hypothesis that kidney transplant patients treated with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin (m-TOR) may increase resistance to physical exercise, which would result in an improvement in the quality of life of these patients.
详细描述
The hypothesis of the present study is that, with respect to calcineurin inhibitors, the mTOR inhibitor-based immunosuppression may alter the physical exercise capacity in renal transplant patients.
This is based on recent data obtained. Regarding metabolism there is evidence that inhibition of mTOR, reduces muscle glucose utilization, as well as, increase fatty acid oxidation. On the other hand, has shown that drugs based on mTOR inhibitors in the context of excess of nutrients improves intracellular glucose uptake in skeletal muscle cells. Through these mechanisms could increase resistance to physical exercise, which would result in an improvement in the quality of life of patients. Nevertheless, there isn't any paper that has explored this hypothesis accurately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant patient's aged between 18 and 60 years old.
- •Heart rate in radial pulse and seated between 50 and 100 bpm.
- •Systolic blood pressure between 100 and 140 and diastolic between 50 to
- •Absence of any clinical physical, psychological or psychiatric condition that would prevent from the protocol described follow-up.
- •Estimated glomerular filtration rate greater than 40 ml / min.
- •Proteinuria < 0.5 g / d.
- •Renal transplantation at least 6 months ago.
- •Immunosuppressant based on calcineurin inhibitors.
- •Hemoglobin > 11 g / dl.
- •Body mass index (BMI) < 35 kg/m
- •Indication for conversion to everolimus and granting of written informed consent.
排除标准
- •Diabetes mellitus
- •Treatment with erythropoiesis stimulating drugs
- •Treatment with β blockers drugs
- •Participation in any clinical trial in the last 30 days prior to the inclusion.
- •Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient.
研究组 & 干预措施
Everolimus
Conversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus)
干预措施: Everolimus (Drug)
结局指标
主要结局
Muscular strength
时间窗: Change from baseline to 6-8 weeks after m-TOR conversion
The principal variable is the increase of the exercise capacity measured by 2 sub-varibles: muscular strenght and decrease of oxygen consumption in the tissues.
Oxygen consumption in the tissues
时间窗: Change from baseline to 6-8 weeks after m-TOR conversion
The principal variable is the increase of the exercise capacity measured by 2 sub-varibles: muscular strenght and decrease of oxygen consumption in the tissues.
次要结局
- Anthropometric measures(Change from baseline to 6-8 weeks after m-TOR conversion)
- Strength of the hand(Change from baseline to 6-8 weeks after m-TOR conversion)
- Metabolic parameters- Cardioventilatory response(Change from baseline to 6-8 weeks after m-TOR conversion)
- Metabolic parameters- Biochemical response(Change from baseline to 6-8 weeks after m-TOR conversion)
- Glucose tolerance test(Change from baseline to 6-8 weeks after m-TOR conversion)
- Blood pressure(Change from baseline to 6-8 weeks after m-TOR conversion)
研究者
Josep M Cruzado
NEPHROLOGIST
Hospital Universitari de Bellvitge