The Effects of Nutritional Intervention on Health Parameters in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT06235762
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2020-08-16
2023-12-15
Brief Summary
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Detailed Description
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This research will recruit participants diagnosed with T2DM (of both sexes aged between 18 and 80 years), at the Diabetes Outpatient Clinic and Hypertension at the Faculty of Medicine of São José do Rio Preto. The interventions will be distributed in quarterly meetings. Participants will be randomly distributed into 2 groups (control and the intervention group). The 40 participants in the control group will only undergo conventional medical evaluation and the 40 Participants in the intervention group will undergo the same medical care, concomitantly with nutritional assessment. Nutritional services will be made up of: A) Application of protocols (1-Nutritional History - Anthropometric, Biochemical and Clinical; 2-Habitual Food Record; 3-Sociodemographic protocol); B) Delivery of nutritional guidelines; C) Preparation of an individualized eating plan (inspired by the Mediterranean Diet and DASH diet with moderate carbohydrate content and restriction of saturated fats).
It is expected that interventions modulate the recovery of nutritional status, dietary inadequacies, parameters anthropometric, biochemical, cardiovascular and clinics, thus improving quality of life and reducing the risk of events in participants with T2DM in long term. In this way, the participants in treatment with nutritional support will be able to achieve greater benefit, maximizing the construction of a process of autonomy to feed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Medical Evaluation
Participants in the control group will only undergo conventional medical evaluation.
No interventions assigned to this group
Conventional Medical Evaluation Plus Nutritional Assessment
Participants in the intervention group will undergo the same medical care, concomitantly with nutritional assessment.
Nutritional Intervention
This clinical trial evaluate the effects of nutritional intervention (individualized and personalized for each patient) on anthropometric, biochemical and cardiovascular parameters in participants with type 2 diabetes mellitus
Interventions
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Nutritional Intervention
This clinical trial evaluate the effects of nutritional intervention (individualized and personalized for each patient) on anthropometric, biochemical and cardiovascular parameters in participants with type 2 diabetes mellitus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Sao Jose do Rio Preto Medical School
OTHER
Responsible Party
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Tatiana Palotta Minari
Principal Investigator
Principal Investigators
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Tatiana Palotta Minari, PhD Student
Role: PRINCIPAL_INVESTIGATOR
State Faculty of Medicine in São José do Rio Preto
Locations
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Faculty of Medicine in São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Countries
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Other Identifiers
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33554520.0.0000.5415
Identifier Type: -
Identifier Source: org_study_id
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