The Effects of Nutritional Intervention on Health Parameters in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2; Diabetes Mellitus Type 2 in Obese; Diabetes; Diabetes Mellitus Non-insulin-dependent; Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nutritional Intervention
Intervention type(s): Behavioral
Intervention description(s): This clinical trial evaluate the effects of nutritional intervention (individualized and personalized for each patient) on anthropometric, biochemical and cardiovascular parameters in participants with type 2 diabetes mellitus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ranzomized Clinical Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Nutritional intervention; Nutrition; Nutritional Strategy; COVID-19; Mediterranean Diet; DASH Diet