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

NCT03793855 | Completed

• 1 other identifier: NUGLIC
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 8

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• FG

  6 months

• SBP

  6 months

• DBP

  6 months

• HDL-c

  6 months

• LDL-c

  6 months

Other Outcomes (2)

• TT

  6 months

• ADD

  6 months

Study Arms (2)

Nutritional Strategy

EXPERIMENTAL

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

Dietary Prescription

ACTIVE COMPARATOR

Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.

Behavioral: Dietary Prescription

Interventions

Nutritional Strategy BEHAVIORAL

Counseling based on dietary goals and mindfulness techniques.

Nutritional Strategy

Dietary Prescription BEHAVIORAL

Dietary prescription according to guidelines.

Dietary Prescription

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (8)

Universidade Federal de Juiz de Fora

Governador Valadares, Brazil

Location

Universidade Federal de Lavras

Lavras, Brazil

Location

Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul

Porto Alegre, Brazil

Location

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Brazil

Location

Instituto Estadual de Cardiologia Aloysio de Castro

Rio de Janeiro, Brazil

Location

Universidade Federal da Bahia

Salvador, Brazil

Location

Hospital do Coracao

São Paulo, 04004-030, Brazil

Location

Universidade Federal de Viçosa

Viçosa, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Aline Marcadenti, PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: May 6, 2019
• Primary Completion: September 28, 2021
• Study Completion: December 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after main paper publication.

Locations

BR (8)