Actively Recruiting

Phase Not Applicable
All Genders
NCT05598203

Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes

Led by Hospital de Clinicas de Porto Alegre · Updated on 2025-03-18

252

Participants Needed

2

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Every year there is an increase in people with diabetes all over the world. Because it is a disease associated with several comorbidities and is increasing, there is a need for more effective treatments. Lifestyle changes combined with medication are the best strategies for the treatment and reduction of comorbidities. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes. A randomized clinical trial will be conducted with adult patients with a previous diagnosis of type 2 diabetes. Patients will be divided into two groups (intervention: nutritional education added the usual care; and control: usual care). The outcomes analyzed will be: glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations.

CONDITIONS

Official Title

Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with a previous diagnosis of type 2 diabetes mellitus
Not Eligible

You will not qualify if you...

  • Patients with other types of diabetes
  • Patients with HbA1C within the therapeutic target or with values greater than 12%
  • Patients with severe neuropathy
  • Patients with chronic kidney disease with glomerular filtration rate less than 30 mL/min/1.73m²
  • Patients with life expectancy less than 6 months
  • Patients with chemical dependence, alcoholism, or use of antipsychotics
  • Patients with autoimmune disease or chronic steroid use
  • Patients with gastroparesis
  • Pregnant or lactating women
  • Patients who had an episode of acute coronary syndrome in the last 60 days
  • Wheelchair users
  • Patients with cognitive, neurological, or psychiatric conditions

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90035003

Actively Recruiting

2

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil, 90035003

Actively Recruiting

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Research Team

J

Jussara C De Almeida, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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