NCT05598203Recruiting
Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes
Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 13 Oct 2022
- Start date
- 6 Sept 2022
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- Type 2 diabetes
- NCT number
- NCT05598203
What you commit to
- Study type: Interventional
- Planned participants: 252
- From 6 Sept 2022 to the primary completion date, 30 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with other types of diabetes
- Chronic kidney disease \[glomerular filtration rate \<30mL/min/1.73m²\]
- Autoimmune disease or chronic steroid use
- Patients who have had an Episode of Acute Coronary Syndrome (ACS) in the last 60 days
- Cognitive, neurological or psychiatric condition
Lab values
- With HbA1C within the therapeutic target or with values greater than 12%
Other
- Severe neuropathy
- Life expectancy \<6 months
- Chemical dependence/alcoholism or use of antipsychotics
- Gastroparesis
- Pregnant or lactating women
- Wheelchair users
Who the study is looking for
- \- Adult patients with a previous diagnosis of type 2 diabetes mellitus
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Universidade Federal do Rio Grande do Sul Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.