Clinical trial NCT06235762: The Effects of Nutritional Intervention on Health Parameters in Participants With Type 2 Diabetes Mellitus
Official title: Nutritional Intervention, Glycemic Control and Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Diabetes Mellitus Type 2 in Obese
Diabetes
Diabetes Mellitus Non-insulin-dependent
Hypertension
Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Nutritional intervention
Nutrition
Nutritional Strategy
COVID-19
Mediterranean Diet
DASH Diet
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-02-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ranzomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The goal of this clinical trial is: 1- Evaluate the effects of nutritional intervention on anthropometric parameters {Weight, Body Mass Index (BMI), Waist Circumference and Waist Hip Ratio (WHR)}, biochemical parameters {Fasting blood glucose, Glycated Hemoglobin (HBA1C), Total Cholesterol ( TC), LDL Cholesterol (LDL-C), HDL Cholesterol (HDL-C) and Triglycerides} and cardiovascular {Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR)}. 2- Evaluate behavioral patterns related to lifestyle, such as skipping breakfast, sleep quality (induction, maintenance and awakenings) and frequency of physical activity. 3-Support knowledge to the participant to build eating autonomy, consequently improving quality of life in the long term.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Weight (kg)
timeFrame: 12 months
measure: Body Mass Index (kg/m²).
timeFrame: 12 months
measure: Waist circumference (cm)
timeFrame: 12 months
measure: Waist Hip Ratio (WHR) [Waist circumference (cm)/hip circumference(cm)]
timeFrame: 12 months
measure: fasting blood glucose concentration (mg/dl)
timeFrame: 12 months
measure: glycated hemoglobin (HBA1C) rates (%)
timeFrame: 12 months
measure: Total Cholesterol ( TC) concentration (mg/dl)
timeFrame: 12 months
measure: LDL Cholesterol (LDL-C) concentration (mg/dl)
timeFrame: 12 months
measure: HDL Cholesterol (HDL-C) concentration (mg/dl)
timeFrame: 12 months
measure: Triglycerides concentration (mg/dl)
timeFrame: 12 months
measure: Systolic Blood Pressure (SBP) (mmHg)
timeFrame: 12 months
measure: Diastolic Blood Pressure (DBP) (mmHg)
timeFrame: 12 months
measure: Heart Rate (HR) beats per minute (bpm)
timeFrame: 12 months
Secondary outcomes:
measure: Skipping breakfast (yes or no)
timeFrame: 12 months
measure: Sleep duration (hours) (more than 6 hours or less than 6 hours)
timeFrame: 12 months
measure: Night awakenings (amount/ number)
timeFrame: 12 months
measure: Physical activity level (sedentary, moderate, advanced)
timeFrame: 12 months
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: Faculty of Medicine in São José do Rio Preto
state: São Paulo
Study officials:
affiliation: State Faculty of Medicine in São José do Rio Preto
name: Tatiana Palotta Minari, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: