NCT05598203 Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes
| NCT ID | NCT05598203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2022-09-06 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 252 participants in total. It began in 2022-09-06 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: \- Adult patients with a previous diagnosis of type 2 diabetes mellitus Exclusion Criteria: * Patients with other types of diabetes * With HbA1C within the therapeutic target or with values greater than 12% * Severe neuropathy * Chronic kidney disease \[glomerular filtration rate \<30mL/min/1.73m²\] * Life expectancy \<6 months * Chemical dependence/alcoholism or use of antipsychotics * Autoimmune disease or chronic steroid use * Gastroparesis * Pregnant or lactating women * Patients who have had an Episode of Acute Coronary Syndrome (ACS) in the last 60 days * Wheelchair users * Cognitive, neurological or psychiatric condition
Contact & Investigator
Jussara C De Almeida, PhD
PRINCIPAL INVESTIGATOR
Federal University of Rio Grande do Sul
Frequently Asked Questions
Who can join the NCT05598203 clinical trial?
This trial is open to participants of all sexes, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05598203 currently recruiting?
Yes, NCT05598203 is actively recruiting participants. Contact the research team at jcalmeida@hcpa.edu.br for enrollment information.
Where is the NCT05598203 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil, Porto Alegre, Brazil.
Who is sponsoring the NCT05598203 clinical trial?
NCT05598203 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Jussara C De Almeida, PhD at Federal University of Rio Grande do Sul. The trial plans to enroll 252 participants.
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