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

Effectiveness of a Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus Users of a Public Health System: NUGLIC Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Nutritional Strategy; Behavioral: Dietary Prescription

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Governador Valadares, Brazil
    • Universidade Federal de Juiz de Fora
  • Lavras, Brazil
    • Universidade Federal de Lavras
  • Porto Alegre, Brazil
    • Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul
  • Porto Alegre, Brazil
    • Universidade Federal de Ciências da Saúde de Porto Alegre
  • Rio De Janeiro, Brazil
    • Instituto Estadual de Cardiologia Aloysio de Castro
  • Salvador, Brazil
    • Universidade Federal da Bahia
  • São Paulo, Brazil, 04004-030
    • Hospital do Coracao
  • Viçosa, Brazil
    • Universidade Federal de Viçosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C	Glycated hemoglobin, in %	6 months
GC	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FG	Fasting glucose, in mg/dL	6 months
SBP	Systolic blood pressure, in mmHg	6 months
DBP	Diastolic blood pressure, in mmHg	6 months
HDL-c	HDL cholesterol, in mg/dL	6 months
LDL-c	LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula	6 months
TC	Total cholesterol, in md/dL	6 months
TG	Serum triglycerides, in mg/dL	6 months
Castelli Index I	Castelli Index I, obtained by the mathematical formula TC/HDL-c	6 months
VLDL-c	VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5	6 months
NHDL	Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c	6 months
Castelli Index II	Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c	6 months
BW	Body weight, in kg	6 months
WC	Waist circumference, in cm	6 months
BMI	Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height*height)	6 months
Cr	Creatinine, in mg/dL	6 months
GFR	Glomerular filtration rate, in ml/min/1.73m2	6 months
Sodium (s)	Serum sodium, in mEq/L	6 months
Sodium (u)	Urinary sodium, in mEq/L	6 months
Potassium (s)	Serum potassium, in mEq/L	6 months
Potassium (u)	Urinary potassium, in mEq/L	6 months
ALB	Albuminuria, in mg/g	6 months
B-PAID	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.	6 months
DSCA	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.	6 months
DQ	Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TT	Therapeutic targets, defined as the proportion of participants who reached the following therapeutic targets: SBP/DBP < 130/80 mmHg; HbA1C <7%; LDL-c <100 mg/dL; BMI < 25 kg/m2 or weight loss > 7%	6 months
ADD	Anti-diabetic drugs, defined as the type and proportion of anti-diabetic drugs used	6 months

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Investigators: Principal Investigator: Aline Marcadenti, PhD, Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NUGLIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and materials will be available upon reasonable request for the corresponding author, after filling a specific form provided by IP-HCor and considering institutional data sharing politics.
• IPD Sharing Time Frame: Data will be available after main paper publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No