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

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ClinicalTrials.gov Identifier: NCT03793855
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

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 as well as to a better quality of life. 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 1 year 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% 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, 180, 270 and 360 days (final consultation). At 120, 150, 210, 240, 300 and 330 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultations of 30 and 270 days will be group meetings). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline, 180 and 360 days; anthropometric indexes and blood pressure will be also evaluated.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Nutritional Strategy Behavioral: Dietary Prescription Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional Strategy
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
Counseling based on dietary goals and mindfulness techniques.

Active Comparator: Dietary Prescription
Individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes.
Behavioral: Dietary Prescription
Dietary prescription according to guidelines.




Primary Outcome Measures :
  1. HbA1C [ Time Frame: 1 year ]
    Glycated hemoglobin, in %


Secondary Outcome Measures :
  1. B-PAID [ Time Frame: 1 year ]
    Quality of life evaluated by the Brazilian version of the Problem Areas in Diabetes Scale

  2. DSCA [ Time Frame: 1 year ]
    Self-care evaluated by the Brazilian version of the Diabetes Self-Care Activities



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: >30 years old with medical diagnosis of T2DM, glycated hemoglobin (HbA1C) ≥7% 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793855


Contacts
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Contact: Aline Marcadenti, PhD (+55)11 30536611 ext 3558 amarcaden@hcor.com.br
Contact: Alexandre Cavalcanti, PhD (+55)11 30536611 ext 8201 abiasi@hcor.com.br

Locations
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Brazil
Hospital do Coracao Recruiting
São Paulo, Brazil, 04004-030
Contact: Aline Marcadenti, PhD         
Sponsors and Collaborators
Hospital do Coracao
Investigators
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Principal Investigator: Aline Marcadenti, PhD Hospital do Coracao

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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT03793855     History of Changes
Other Study ID Numbers: NUGLIC
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases