Multicomponent Intervention on Lifestyle, Anthropometric Measurements, Glycemic Control and Quality of Life in Patients Obese People With Type II Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Glycated hemoglobin
研究概览
简要总结
The main objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with Type II Diabetes (DM2) in three places at the Algodonera Health Center of the Care Management Integrated in Talavera de la Reina.
详细描述
Diabetes Mellitus (DM) is a chronic process that is not only important for its incidence and prevalence, but also for its complications. DM is responsible for cardiovascular complications that have high and premature mortality and a significant impact on quality of life. Diet control is one of the most effective therapeutic measures at all stages of diabetes management. It is important to promote healthy eating patterns that increase the consumption of foods with high nutritional value, in appropriate proportions, to improve overall health.
The objective of this study will be to evaluate the effectiveness of a multicomponent intervention on nutritional recommendations and physical activity on glycemic control in obese patients with Type II Diabetes (DM2) in three places at the Algodonera Health Center of the Integrated Care Management. from Talavera de la Reina.
For this purpose, a clinical trial will be carried out with two parallel arms, random assignment and blind evaluation by third parties. The study will be carried out on obese patients with DM2 between 40 and 75 years old at the "Algodonera" Health Center of the Integrated Care Management of Talavera de la Reina over a period of 1 year, from the subject's admission to the hospital. study until the last follow-up evaluation at one year. Selected patients must have a Barthel index > 90 and must travel to the health center independently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a known diagnosis of DM
- •Obese patients with a BMI >
- •Patients with Barthel index > 90
- •Possibility of walking to the Health Center.
- •Know how to read and write
- •That they agree to participate in the study and sign the informed consent.
排除标准
- •Patients with Type I DM.
- •Inability to perform physical exercise, defined as such, that appears in your current medical history or that your PCP considers.
- •Patients with complete deafness.
- •Patients with blindness.
- •Moderate or severe cognitive impairment.
- •Participation in another clinical trial.
- •Pregnant or breastfeeding women
- •Any condition, laboratory parameter or concomitant therapy that, in the opinion of the investigator, may be a risk to the potential participant or that participation in the study is not in the best interest of the patient.
结局指标
主要结局
Glycated hemoglobin
时间窗: 12 months after the start of the study
We expect a difference in the mean glycated hemoglobin between the control group and the experimental group of 0.6 units 12 months after starting participation in the study.
次要结局
- Lipid profile (HDL)(12 months after the start of the study)
- Lipid profile (LDL)(12 months after the start of the study)
- Glomerular filtration rate(12 months after the start of the study)
- Body Mass Index(12 months after the start of the study)
- Changes in Medication cholesterol(12 months after the start of the study)
- Triglycerides(12 months after the start of the study)
- Proteinuria(12 months after the start of the study)
- Weight(12 months after the start of the study)
- Circumference weist(12 months after the start of the study)
- SDSCA - Summary of Diabetes Self-Care Activities measure(12 months after the start of the study)
- IPAQ - International Physical Activity Questionnaire(12 months after the start of the study)
- PREDIMED - Prevention with Mediterranean diet(12 months after the start of the study)
- Mortality of related to cardiovascular events(12 months after the start of the study)
- Morbility of related to cardiovascular events(12 months after the start of the study)
- Changes in medication diabetes(12 months after the start of the study)
- Changes in Medication high blood pressure(12 months after the start of the study)
- Quality of life - Euroqol-5D(12 months after the start of the study)