Clinical trial NCT03793855: Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)
Official title: Effectiveness of a Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus Users of a Public Health System: NUGLIC Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 370
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

* 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.

Primary outcomes:
measure: HbA1C
timeFrame: 6 months
measure: GC
timeFrame: 6 months
Secondary outcomes:
measure: FG
timeFrame: 6 months
measure: SBP
timeFrame: 6 months
measure: DBP
timeFrame: 6 months
measure: HDL-c
timeFrame: 6 months
measure: LDL-c
timeFrame: 6 months
measure: TC
timeFrame: 6 months
measure: TG
timeFrame: 6 months
measure: Castelli Index I
timeFrame: 6 months
measure: VLDL-c
timeFrame: 6 months
measure: NHDL
timeFrame: 6 months
measure: Castelli Index II
timeFrame: 6 months
measure: BW
timeFrame: 6 months
measure: WC
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: Cr
timeFrame: 6 months
measure: GFR
timeFrame: 6 months
measure: Sodium (s)
timeFrame: 6 months
measure: Sodium (u)
timeFrame: 6 months
measure: Potassium (s)
timeFrame: 6 months
measure: Potassium (u)
timeFrame: 6 months
measure: ALB
timeFrame: 6 months
measure: B-PAID
timeFrame: 6 months
measure: DSCA
timeFrame: 6 months
measure: DQ
timeFrame: 6 months
Other outcomes:
measure: TT
timeFrame: 6 months
measure: ADD
timeFrame: 6 months
Locations:
city: Governador Valadares
country: Brazil
facility: Universidade Federal de Juiz de Fora
city: Lavras
country: Brazil
facility: Universidade Federal de Lavras
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
city: Rio De Janeiro
country: Brazil
facility: Instituto Estadual de Cardiologia Aloysio de Castro
city: Salvador
country: Brazil
facility: Universidade Federal da Bahia
city: São Paulo
country: Brazil
facility: Hospital do Coracao
city: Viçosa
country: Brazil
facility: Universidade Federal de Viçosa
Study officials:
affiliation: Hospital do Coracao
name: Aline Marcadenti, PhD
role: PRINCIPAL_INVESTIGATOR
References: