Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Glicemic control
研究概览
简要总结
Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients.
详细描述
Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients. The initial step will be performed analysis of composition and diet quality, and anthropometric and laboratory evaluation. After initial assessment and meeting the criteria eligibility, patients will be randomized to receive nutritional counseling from diet quality (intervention group) or usual diet in according to current nutritional recommendations (control group). Both the groups will receive adjust caloric intake as the nutritional needs of each patient. Patients will be followed over six months, on a monthly basis from hospital visits or telephone monitoring. The outcomes evaluated will be: the achievement of therapeutic targets (fasting blood glucose levels between 70-130 mg / dL, HbA1c<7%, LDL cholesterol <100 mg/dL and triglycerides <150 mg/dL); use of antidiabetic drugs, lipid-lowering and antihypertensive drugs, and adherence to necessary dietary changes.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients aged ≥ 30 years;
- •Body mass index ≤ 40kg/m²;
- •Serum creatinine <2 mg/dL;
- •Serum triglycerides <400 mg/dL.
排除标准
- •Cognitive impairment (clinical suspicion);
- •Illiterate;
- •Liver function tests and abnormal thyroid;
- •Urinary tract infection carriers, kidney disease and heart failure uncompensated (grade III or IV);
- •Active wasting disease diagnosis (Cancer, Acquired Immune Deficiency Syndrome);
- •Metabolic control within the therapeutic target;
- •Patients with dietary guidance by nutritionist in less than three months.
研究组 & 干预措施
Usual Diet Guidance
The patients will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed in outpatient patients treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre.
干预措施: Usual Diet Guidance (Other)
Nutritional Counseling
The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material.
干预措施: Nutritional Counseling (Other)
结局指标
主要结局
Glicemic control
时间窗: six months
Obtaining HbA1c \<7% and/or reduction in HbA1c at least 1% of baseline
次要结局
- Obtaining therapeutic target(six months)
- Adherence to nutritional counseling(six months)