Skip to main content
OpenTrials
Completed

NCT Number: NCT03793855

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Juiz de Fora, Governador Valadares, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Strategy

Behavioral

Counseling based on dietary goals and mindfulness techniques.

Dietary Prescription

Behavioral

Dietary prescription according to guidelines.

Primary outcomes

  1. HbA1C

    Time frame: 6 months

    Glycated hemoglobin, in %

  2. GC

    Time frame: 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 outcomes

  1. FG

    Time frame: 6 months

    Fasting glucose, in mg/dL

  2. SBP

    Time frame: 6 months

    Systolic blood pressure, in mmHg

  3. DBP

    Time frame: 6 months

    Diastolic blood pressure, in mmHg

  4. HDL-c

    Time frame: 6 months

    HDL cholesterol, in mg/dL

  5. LDL-c

    Time frame: 6 months

    LDL cholesterol, in mg/dL; it will be obtained by the Martin´s mathematical formula

  6. TC

    Time frame: 6 months

    Total cholesterol, in md/dL

  7. TG

    Time frame: 6 months

    Serum triglycerides, in mg/dL

  8. Castelli Index I

    Time frame: 6 months

    Castelli Index I, obtained by the mathematical formula TC/HDL-c

  9. VLDL-c

    Time frame: 6 months

    VLDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TG/5

  10. NHDL

    Time frame: 6 months

    Non-HDL cholesterol, in mg/dL; it will be obtained by the mathematical formula TC - HDL-c

  11. Castelli Index II

    Time frame: 6 months

    Castelli Index II, obtained by the mathematical formula LDL-c/HDL-c

  12. BW

    Time frame: 6 months

    Body weight, in kg

  13. WC

    Time frame: 6 months

    Waist circumference, in cm

  14. BMI

    Time frame: 6 months

    Body mass index, in kg/m2; it will be obtained by the mathematical formula (BW/height*height)

  15. Cr

    Time frame: 6 months

    Creatinine, in mg/dL

  16. GFR

    Time frame: 6 months

    Glomerular filtration rate, in ml/min/1.73m2

  17. Sodium (s)

    Time frame: 6 months

    Serum sodium, in mEq/L

  18. Sodium (u)

    Time frame: 6 months

    Urinary sodium, in mEq/L

  19. Potassium (s)

    Time frame: 6 months

    Serum potassium, in mEq/L

  20. Potassium (u)

    Time frame: 6 months

    Urinary potassium, in mEq/L

  21. ALB

    Time frame: 6 months

    Albuminuria, in mg/g

  22. B-PAID

    Time frame: 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.

  23. DSCA

    Time frame: 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.

  24. DQ

    Time frame: 6 months

    Diet quality, evaluated by the modified Alternative Healthy Eating Index (mAHEI)

Other outcomes

  1. TT

    Time frame: 6 months

    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%

  2. ADD

    Time frame: 6 months

    Anti-diabetic drugs, defined as the type and proportion of anti-diabetic drugs used

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 4, 2019
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.