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Diabetes Mellitus, Type 2NCT03793855

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

A study testing Nutritional Strategy and Dietary Prescription in people with Diabetes Mellitus, Type 2, run by Hospital do Coracao at 8 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Nutritional Strategy and Dietary Prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
8 sitesBrazil
Study dates
6 May 2019to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Brazil8 sites

  • Universidade Federal de Juiz de Fora

    Governador Valadares

  • Universidade Federal de Lavras

    Lavras

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

    Porto Alegre

  • Universidade Federal de Ciências da Saúde de Porto Alegre

    Porto Alegre

  • Instituto Estadual de Cardiologia Aloysio de Castro

    Rio de Janeiro

  • Universidade Federal da Bahia

    Salvador

  • Hospital do Coracao

    São Paulo, 04004-030

  • Universidade Federal de Viçosa

    Viçosa

Other trials in Brazil

About this study

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

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.

Being tested
Nutritional Strategy, Dietary Prescription
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional StrategyBehavioural

    Counseling based on dietary goals and mindfulness techniques.

  • Dietary PrescriptionBehavioural

    Dietary prescription according to guidelines.

Study groups in NCT03793855
Study groupRoleWhat they receive
Nutritional StrategyExperimentalNutritional 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).
Receives: Behavioral: Nutritional Strategy
Dietary PrescriptionActive comparatorIndividualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.
Receives: Behavioral: Dietary Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1C

    Glycated hemoglobin, in %

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (24)

  1. FG

    Fasting glucose, in mg/dL

    Measured: 6 months

  2. SBP

    Systolic blood pressure, in mmHg

    Measured: 6 months

  3. DBP

    Diastolic blood pressure, in mmHg

    Measured: 6 months

  4. HDL-c

    HDL cholesterol, in mg/dL

    Measured: 6 months

  5. LDL-c

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

    Measured: 6 months

  6. TC

    Total cholesterol, in md/dL

    Measured: 6 months

  7. TG

    Serum triglycerides, in mg/dL

    Measured: 6 months

  8. Castelli Index I

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

    Measured: 6 months

  9. VLDL-c

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

    Measured: 6 months

  10. NHDL

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

    Measured: 6 months

  11. Castelli Index II

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

    Measured: 6 months

  12. BW

    Body weight, in kg

    Measured: 6 months

  13. WC

    Waist circumference, in cm

    Measured: 6 months

  14. BMI

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

    Measured: 6 months

  15. Cr

    Creatinine, in mg/dL

    Measured: 6 months

  16. GFR

    Glomerular filtration rate, in ml/min/1.73m2

    Measured: 6 months

  17. Sodium (s)

    Serum sodium, in mEq/L

    Measured: 6 months

  18. Sodium (u)

    Urinary sodium, in mEq/L

    Measured: 6 months

  19. Potassium (s)

    Serum potassium, in mEq/L

    Measured: 6 months

  20. Potassium (u)

    Urinary potassium, in mEq/L

    Measured: 6 months

  21. ALB

    Albuminuria, in mg/g

    Measured: 6 months

  22. 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.

    Measured: 6 months

  23. 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.

    Measured: 6 months

  24. DQ

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start6 May 2019
  3. Primary completion28 Sep 2021
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793855
Sponsor's protocol ID
NUGLIC
Status last verified
Feb 2022
First submitted
3 Jan 2019
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bauer J, Ayala FO, Marcadenti A, Machado RHV, Cristina Bersch-Ferreira A, Moreira MFS, Beretta MV, Feoli AMP, Busnello FM. Consumption of Ultra-Processed Foods and Metabolic Parameters in Type 2 Diabetes Mellitus: A Cross-Sectional Study. Int J Environ Res Public Health. 2025 Aug 14;22(8):1275. doi: 10.3390/ijerph22081275.

    PubMed 40869860

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Strategy and Dietary Prescription in people with Diabetes Mellitus, Type 2, run by Hospital do Coracao at 8 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1C (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03793855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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