NCT06235762Completed
The Effects of Nutritional Intervention on Health Parameters in Participants With Type 2 Diabetes Mellitus
Nutritional Intervention, Glycemic Control and Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 1 Feb 2024
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the effects of nutritional intervention on anthropometric, biochemical and cardiovascular parameters in participants with type 2 diabetes mellitus. Participants will be distributed into 2 groups (control and intervention). Participants in the control group will only undergo conventional medical assessment and participants in the intervention group will receive the same medical care, concomitantly with nutritional assessment. The nutritional intervention is expected to reduce anthropometric data, glycemic and cardiovascular parameters in participants with T2DM, as opposed to the control group.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 22 Dec 2023
- Start date
- 16 Aug 2020
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Diseases
- Obesity, High blood pressure, Type 2 diabetes
- NCT number
- NCT06235762
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 16 Aug 2020 to the primary completion date, 15 Nov 2023
- 1 site 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.
Criteria the registry did not label
- Inclusion criteria - Participants with:
- Age: Adults above 18 years to below 80 years.
- Diagnosis of the disease: T2DM, that is, fasting blood glucose values equal to or greater than 126 mg/dL and glycated hemoglobin equal to or greater than 6.5%.
- Gender: Male and female
- Availability to participate in quarterly meetings during a period of 36 months.
- Nutritional status: initial diagnosis of overweight or obesity, that is, with BMI above 24.9kg/m².
- Sedentary.
- Exclusion criteria - Participants who:
- They had difficulties answering the requested instruments.
- They demonstrated impediments to assiduity in data collection.
- They did not present a diagnosis of T2DM.
- They were using insulin therapy.
- They were using SGLT-2 inhibitors and/or GLP-1 analogues.
- People with Chronic Kidney Disease.
- Eutrophic or malnourished.
- Physical exercisers, that is, more than 150 minutes of moderate to intense exercise per week.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine in São José do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.