Diabetes Mellitus, Type 2
Conditions
Interventions
This is a randomized, two-arm clinical trial. The sample size calculation was based on the difference between the means of two dependent groups, considering a minimum difference in %HbA1c of 1%. A sam
Sponsors
Universidade Federal de Sergipe
Universidade Federal de Sergipe
Eligibility
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: Individuals with type 2 diabetes mellitus aged between 20 and 70 years, of both genders, assisted by Primary Health Care, from the Unified Health System (SUS) in the State of Sergipe, and who are users of the public health network residing in both urban and rural areas.
Exclusion criteria
Exclusion criteria: Individuals who are part of any group/study with an approach to food and nutritional education or other intervention, as well as pregnant women, patients using a feeding tube, patients who have undergone any surgical procedure in the last month, and patients with limiting factors for food intake due to their disease, such as head and neck cancer, HIV, and Chronic Obstructive Pulmonary Disease, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect to find a reduction in the percentage of glycated hemoglobin (%HbA1c), fasting glucose, triacylglycerol, total cholesterol, HDL-c, LDL-c and non-HDL. To do this, a total of 15 mL of blood will be collected from the participants after a 10-hour overnight fast. The samples will be distributed in tubes without anticoagulants to obtain serum for the analysis of fasting glucose, triacylglycerols (TAG), total cholesterol, HDL-c, creatinine, C-peptide and insulin, and in tubes with the anticoagulant EDTA to determine the percentage of glycated hemoglobin (%HbA1c). Fasting serum glucose and total cholesterol concentrations will be determined by enzymatic methods. The determination of %HbA1c will be carried out by the liquid chromatography method - HPLC. Serum insulin and C-peptide will be determined by chemiluminescence and electrochemiluminescence methods, respectively. TAG, HDL-c and creatinine concentrations will be obtained using colorimetric methods. The LDL-c value will be obtained using the equation LDL-c = TC - HDL-c - TG/x, where x ranges from 3.1 to 11.9. Non-HDL-c fraction values will also be obtained from the difference between total cholesterol and HDL-c. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect to find differences in anthropometric variables (weight, Body Mass Index, and waist circumference). Weight and height will be measured to calculate the Body Mass Index (BMI) and the result will be analyzed according to the classification proposed by the World Health Organization. Waist circumference (WC) will be measured with the patient standing, feet together, and arms extended along the body, using a non-stretchable tape measure. It will be positioned at the midpoint between the last rib and the iliac crest. In the case of patients with an overweight/obese BMI, the measurement was taken at the point of greatest circumference. The reading was taken at the moment of expiration and was classified as increased risk for metabolic complications associated with obesity when greater than 80 cm for women and 94 cm for men, or substantially increased when greater than 88 cm for women and 102 cm for men.;We expect to reduce serum C-Reactive Protein after the Food and Nutrition Education actions, which will be determined by the immunoturbidimetry method.;We expect to see an improvement in the quality of the diet and food consumption of the individuals after the Food and Nutrition Education actions, through the use of diet quality indices and the determination of dietary patterns, which will be obtained from the 24-hour recalls (Rec24h), 3 of which will be collected at the beginning and 3 at the end of the study. | — |
Countries
Brazil
Contacts
Public ContactLiliane Pires
Universidade Federal de Sergipe
Outcome results
None listed