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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793855
• Other study ID #: NUGLIC
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: December 30, 2022
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Nutritional Strategy
Counseling based on dietary goals and mindfulness techniques.
• Dietary Prescription
Dietary prescription according to guidelines.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Juiz de Fora	Governador Valadares
Brazil	Universidade Federal de Lavras	Lavras
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	ADD	Anti-diabetic drugs, defined as the type and proportion of anti-diabetic drugs used	6 months
Primary	HbA1C	Glycated hemoglobin, in %	6 months
Primary	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	FG	Fasting glucose, in mg/dL	6 months
Secondary	SBP	Systolic blood pressure, in mmHg	6 months
Secondary	DBP	Diastolic blood pressure, in mmHg	6 months
Secondary	HDL-c	HDL cholesterol, in mg/dL	6 months
Secondary	LDL-c	LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula	6 months
Secondary	TC	Total cholesterol, in md/dL	6 months
Secondary	TG	Serum triglycerides, in mg/dL	6 months
Secondary	Castelli Index I	Castelli Index I, obtained by the mathematical formula TC/HDL-c	6 months
Secondary	VLDL-c	VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5	6 months
Secondary	NHDL	Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c	6 months
Secondary	Castelli Index II	Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c	6 months
Secondary	BW	Body weight, in kg	6 months
Secondary	WC	Waist circumference, in cm	6 months
Secondary	BMI	Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height*height)	6 months
Secondary	Cr	Creatinine, in mg/dL	6 months
Secondary	GFR	Glomerular filtration rate, in ml/min/1.73m2	6 months
Secondary	Sodium (s)	Serum sodium, in mEq/L	6 months
Secondary	Sodium (u)	Urinary sodium, in mEq/L	6 months
Secondary	Potassium (s)	Serum potassium, in mEq/L	6 months
Secondary	Potassium (u)	Urinary potassium, in mEq/L	6 months
Secondary	ALB	Albuminuria, in mg/g	6 months
Secondary	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
Secondary	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
Secondary	DQ	Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)	6 months