Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Nutritional Strategy; Behavioral: Dietary Prescription

• Registration Number: NCT03793855
• Lead Sponsor: Hospital do Coracao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Study Start: 2019-05-06
• Primary Completion: 2021-09-28
• Status Verified: 2022-02
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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

• Patients with type 1 DM (T1DM), latent autoimmune diabetes in adults (LADA) or HbA1C ≥ 12%;
• Severe neuropathy;
• Chronic kidney disease;
• Active cancer or life expectancy <6 months;
• Chemical dependence or use of antipsychotic drugs;
• Autoimmune disease or chronic use of steroids;
• Gastroparesis;
• Pregnancy, lactation, gestational DM;
• Acute coronary syndrome (ACS) in the last 60 days;
• Wheelchair users;
• Extreme obesity (body mass index [BMI] ≥40kg/m²);
• Cognitive, neurological or psychiatric condition that prevents participation in the study;
• Participation in other clinical trials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Strategy	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).
Dietary Prescription	Dietary Prescription	Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.

Primary Outcome Measures

Name	Time	Method
HbA1C	6 months	Glycated hemoglobin, in %
GC	6 months	Glycemic control, defined as either having HbA1C \> 7% at baseline and achieving HbA1C ≤ 7% after follow-up or having HbA1C \< 7% at baseline and reducing anti-diabetic drugs after follow-up.

Secondary Outcome Measures

Name	Time	Method
SBP	6 months	Systolic blood pressure, in mmHg
HDL-c	6 months	HDL cholesterol, in mg/dL
TC	6 months	Total cholesterol, in md/dL
Cr	6 months	Creatinine, in mg/dL
Sodium (u)	6 months	Urinary sodium, in mEq/L
LDL-c	6 months	LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula
VLDL-c	6 months	VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5
BW	6 months	Body weight, in kg
BMI	6 months	Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height\*height)
DQ	6 months	Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)
DBP	6 months	Diastolic blood pressure, in mmHg
Castelli Index II	6 months	Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c
Potassium (u)	6 months	Urinary potassium, in mEq/L
ALB	6 months	Albuminuria, in mg/g
FG	6 months	Fasting glucose, in mg/dL
Potassium (s)	6 months	Serum potassium, in mEq/L
Castelli Index I	6 months	Castelli Index I, obtained by the mathematical formula TC/HDL-c
NHDL	6 months	Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c
WC	6 months	Waist circumference, in cm
Sodium (s)	6 months	Serum sodium, in mEq/L
B-PAID	6 months	Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale. The scale consists of 20 questions; it uses a score from 0 to 100, in which the maximum score is configured as greater suffering. The possible response options are divided on a 5-point Likert scale, ranging from: "Not a problem=0", "Small problem=1", "Moderate problem=2", "Almost serious problem=3", "Serious problem=4". A cut-off point equal or greater 40 indicates a high degree of emotional distress.
DSCA	6 months	Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities. The questionnaire has six domains and 15 items for assessment of the diabetes self-care; it is based on the number of days per week in which the respondent has a given behavior, with each item scoring from 0 to 7 points (i.e. 0 is the least desirable situation and 7 is the most desirable one). At least five days for each self-care activity is considered adequate.
GFR	6 months	Glomerular filtration rate, in ml/min/1.73m2
TG	6 months	Serum triglycerides, in mg/dL

Trial Locations

Locations (8)

Universidade Federal de Juiz de Fora; 🇧🇷 Governador Valadares, Brazil

Universidade Federal de Lavras; 🇧🇷 Lavras, Brazil

Universidade Federal de Ciências da Saúde de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

Instituto Estadual de Cardiologia Aloysio de Castro; 🇧🇷 Rio De Janeiro, Brazil

Universidade Federal da Bahia; 🇧🇷 Salvador, Brazil

Hospital do Coracao; 🇧🇷 São Paulo, Brazil

Universidade Federal de Viçosa; 🇧🇷 Viçosa, Brazil

Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul; 🇧🇷 Porto Alegre, Brazil