Nutritional Intervention, Glycemic Control and Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Body Mass Index (kg/m²).
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of nutritional intervention on anthropometric, biochemical and cardiovascular parameters in participants with type 2 diabetes mellitus. Participants will be distributed into 2 groups (control and intervention). Participants in the control group will only undergo conventional medical assessment and participants in the intervention group will receive the same medical care, concomitantly with nutritional assessment. The nutritional intervention is expected to reduce anthropometric data, glycemic and cardiovascular parameters in participants with T2DM, as opposed to the control group.
详细描述
The goal of this clinical trial is: 1- Evaluate the effects of nutritional intervention on anthropometric parameters {Weight, Body Mass Index (BMI), Waist Circumference and Waist Hip Ratio (WHR)}, biochemical parameters {Fasting blood glucose, Glycated Hemoglobin (HBA1C), Total Cholesterol ( TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and Triglycerides} and cardiovascular {Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR)}. 2- Evaluate behavioral patterns related to lifestyle, such as skipping breakfast, sleep quality (induction, maintenance and awakenings) and frequency of physical activity. 3-Support knowledge to the participant to build eating autonomy, consequently improving quality of life in the long term.
This research will recruit participants diagnosed with T2DM (of both sexes aged between 18 and 80 years), at the Diabetes Outpatient Clinic and Hypertension at the Faculty of Medicine of São José do Rio Preto. The interventions will be distributed in quarterly meetings. Participants will be randomly distributed into 2 groups (control and the intervention group). The 40 participants in the control group will only undergo conventional medical evaluation and the 40 Participants in the intervention group will undergo the same medical care, concomitantly with nutritional assessment. Nutritional services will be made up of: A) Application of protocols (1-Nutritional History - Anthropometric, Biochemical and Clinical; 2-Habitual Food Record; 3-Sociodemographic protocol); B) Delivery of nutritional guidelines; C) Preparation of an individualized eating plan (inspired by the Mediterranean Diet and DASH diet with moderate carbohydrate content and restriction of saturated fats).
It is expected that interventions modulate the recovery of nutritional status, dietary inadequacies, parameters anthropometric, biochemical, cardiovascular and clinics, thus improving quality of life and reducing the risk of events in participants with T2DM in long term. In this way, the participants in treatment with nutritional support will be able to achieve greater benefit, maximizing the construction of a process of autonomy to feed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria - Participants with:
- •Age: Adults above 18 years to below 80 years.
- •Diagnosis of the disease: T2DM, that is, fasting blood glucose values equal to or greater than 126 mg/dL and glycated hemoglobin equal to or greater than 6.5%.
- •Gender: Male and female
- •Availability to participate in quarterly meetings during a period of 36 months.
- •Nutritional status: initial diagnosis of overweight or obesity, that is, with BMI above 24.9kg/m².
- •Sedentary.
排除标准
- •Participants who:
- •They had difficulties answering the requested instruments.
- •They demonstrated impediments to assiduity in data collection.
- •They did not present a diagnosis of T2DM.
- •They were using insulin therapy.
- •They were using SGLT-2 inhibitors and/or GLP-1 analogues.
- •People with Chronic Kidney Disease.
- •Eutrophic or malnourished.
- •Physical exercisers, that is, more than 150 minutes of moderate to intense exercise per week.
结局指标
主要结局
Body Mass Index (kg/m²).
时间窗: 12 months
Evaluate the impact of nutritional intervention on Body Mass Index (kg/m²) between the 0th and 12th month.
glycated hemoglobin (HBA1C) rates (%)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Glycated Hemoglobin (HBA1C) (%) between the 0th and 12th month.
Triglycerides concentration (mg/dl)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Triglycerides(mg/dl) between the 0th and 12th month.
Waist circumference (cm)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Waist circumference (cm) between the 0th and 12th month.
Total Cholesterol ( TC) concentration (mg/dl)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Total Cholesterol ( TC) (mg/dl) between the 0th and 12th month.
fasting blood glucose concentration (mg/dl)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Fasting blood glucose (mg/dl) between the 0th and 12th month.
Systolic Blood Pressure (SBP) (mmHg)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Systolic Blood Pressure (SBP) (mmHg) between the 0th and 12th month.
Diastolic Blood Pressure (DBP) (mmHg)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.
Heart Rate (HR) beats per minute (bpm)
时间窗: 12 months
Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.
Weight (kg)
时间窗: 12 months
Evaluate the impact of nutritional intervention on weight (kg) between the 0th and 12th month.
Waist Hip Ratio (WHR) [Waist circumference (cm)/hip circumference(cm)]
时间窗: 12 months
Evaluate the impact of nutritional intervention on Waist Hip Ratio (WHR) between the 0th and 12th month.
LDL Cholesterol (LDL-C) concentration (mg/dl)
时间窗: 12 months
Evaluate the impact of nutritional intervention on LDL Cholesterol (LDL-C) (mg/dl) between the 0th and 12th month.
HDL Cholesterol (HDL-C) concentration (mg/dl)
时间窗: 12 months
Evaluate the impact of nutritional intervention on HDL Cholesterol (HDL-C)(mg/dl) between the 0th and 12th month.
次要结局
- Sleep duration (hours) (more than 6 hours or less than 6 hours)(12 months)
- Night awakenings (amount/ number)(12 months)
- Skipping breakfast (yes or no)(12 months)
- Physical activity level (sedentary, moderate, advanced)(12 months)
研究者
Tatiana Palotta Minari
Principal Investigator
Sao Jose do Rio Preto Medical School