Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)
Study Details
Study Description
Brief Summary
Adherence to a healthy dietary pattern is part of the self-care of patients with type 2 diabetes mellitus (T2DM), and may contribute substantially to therapeutic target goals and to a better quality of life as well. However, not all nutritional recommendations aimed at these patients are easily applicable in clinical practice. The primary objective of the study is to evaluate the effectiveness of a nutritional strategy for glycemic control in patients with T2DM users of a Public Health System after 6 months of follow-up. As secondary objectives, we will evaluate the impact of the proposed strategy on self-care and on the quality of life of the patients. In this randomized multicenter open-label randomized trial, 370 patients >30 years old with T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who have not received or received nutritional counseling for at least 06 months will be enrolled. Patients allocated to the control group will receive individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes. Nutritional counseling in the intervention group will be performed based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance will be based on feasible goals built together (patient and nutritionist), and no diet will be prescribed for intervention group. In both groups, patients will receive glymeters for residential self-monitoring of glycemic levels. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and blood pressure will be also evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nutritional Strategy Nutritional counseling based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; dietary guidance based on feasible goals built together (patient and nutritionist). |
Behavioral: Nutritional Strategy
Counseling based on dietary goals and mindfulness techniques.
|
| Active Comparator: Dietary Prescription Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes. |
Behavioral: Dietary Prescription
Dietary prescription according to guidelines.
|
Outcome Measures
Primary Outcome Measures
- HbA1C [6 months]
Glycated hemoglobin, in %. Glycemic control will be considered if the participant decreases the medication during the study and maintains HbA1C at the end of the follow-up; or if the patient maintains the medication throughout the study and decreases HbA1C at the end of the follow-up.
Secondary Outcome Measures
- B-PAID [6 months]
Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale
- FG [6 months]
Fasting glucose, in mg/dL
- DSCA [6 months]
Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities
- LDL-c [6 months]
LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula
- HDL-c [6 months]
HDL cholesterol, in mg/dL
- TC [6 months]
Total cholesterol, in md/dL
- TG [6 months]
Serum triglycerides, in mg/dL
- VLDL-c [6 months]
VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5
- NHDL [6 months]
Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c
- Castelli Index I [6 months]
Castelli Index I, obtained by the mathematical formula TC/HDL-c
- Castelli Index II [6 months]
Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c
- SBP [6 months]
Systolic blood pressure, in mmHg
- DBP [6 months]
Diastolic blood pressure, in mmHg
- BW [6 months]
Body weight, in kg
- WC [6 months]
Waist circumference, in cm
- BMI [6 months]
Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height*height)
Eligibility Criteria
Criteria
Inclusion Criteria: >30 years old with medical diagnosis of T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who have not received or received nutritional counseling for at least 06 months.
Exclusion Criteria:
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Patients with type 1 DM (T1DM), latent autoimmune diabetes in adults (LADA) or HbA1C ≥ 12%;
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Severe neuropathy;
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Chronic kidney disease;
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Active cancer or life expectancy <6 months;
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Chemical dependence or use of antipsychotic drugs;
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Autoimmune disease or chronic use of steroids;
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Gastroparesis;
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Pregnancy, lactation, gestational DM;
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Acute coronary syndrome (ACS) in the last 60 days;
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Wheelchair users;
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Extreme obesity (body mass index [BMI] ≥40kg/m²);
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Cognitive, neurological or psychiatric condition that prevents participation in the study;
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Participation in other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade Federal de Juiz de Fora | Governador Valadares | Brazil | ||
| 2 | Universidade Federal de Lavras | Lavras | Brazil | ||
| 3 | Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul | Porto Alegre | Brazil | ||
| 4 | Universidade Federal de Ciências da Saúde de Porto Alegre | Porto Alegre | Brazil | ||
| 5 | Instituto Estadual de Cardiologia Aloysio de Castro | Rio De Janeiro | Brazil | ||
| 6 | Universidade Federal da Bahia | Salvador | Brazil | ||
| 7 | Hospital do Coracao | São Paulo | Brazil | 04004-030 | |
| 8 | Universidade Federal de Viçosa | Viçosa | Brazil |
Sponsors and Collaborators
- Hospital do Coracao
Investigators
- Principal Investigator: Aline Marcadenti, PhD, Hospital do Coracao
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NUGLIC