The goal of this clinical trial is to evaluate the effects of nutritional intervention onanthropometric, biochemical and cardiovascular parameters in participants with type 2diabetes mellitus. Participants will be distributed into 2 groups (control andintervention). Participants in the control group will only undergo conventional medicalassessment and participants in the intervention group will receive the same medical care,concomitantly with nutritional assessment. The nutritional intervention is expected toreduce anthropometric data, glycemic and cardiovascular parameters in participants withT2DM, as opposed to the control group.
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.
Behavioral: Nutritional Intervention
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
- 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.
- Exclusion criteria - 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.
Faculty of Medicine in São José do Rio Preto
São José do Rio Preto 3448639, São Paulo 3448433, Brazil
Tatiana Palotta Minari, PhD Student, Principal Investigator
State Faculty of Medicine in São José do Rio Preto