The Effects of Nutritional Intervention on Health Parameters in Participants With Type 2 Diabetes Mellitus

Hypertension Clinical Trial

Official title:

Nutritional Intervention, Glycemic Control and Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06235762
• Other study ID #: 33554520.0.0000.5415
• Status: Completed
• Phase: N/A
• Start date: August 16, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Sao Jose do Rio Preto Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus Non-insulin-dependent
• Diabetes Mellitus Type 2
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Brazil	Faculty of Medicine in São José do Rio Preto	São José do Rio Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto Medical School	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (kg)	Evaluate the impact of nutritional intervention on weight (kg) between the 0th and 12th month.	12 months
Primary	Body Mass Index (kg/m²).	Evaluate the impact of nutritional intervention on Body Mass Index (kg/m²) between the 0th and 12th month.	12 months
Primary	Waist circumference (cm)	Evaluate the impact of nutritional intervention on Waist circumference (cm) between the 0th and 12th month.	12 months
Primary	Waist Hip Ratio (WHR) [Waist circumference (cm)/hip circumference(cm)]	Evaluate the impact of nutritional intervention on Waist Hip Ratio (WHR) between the 0th and 12th month.	12 months
Primary	fasting blood glucose concentration (mg/dl)	Evaluate the impact of nutritional intervention on Fasting blood glucose (mg/dl) between the 0th and 12th month.	12 months
Primary	glycated hemoglobin (HBA1C) rates (%)	Evaluate the impact of nutritional intervention on Glycated Hemoglobin (HBA1C) (%) between the 0th and 12th month.	12 months
Primary	Total Cholesterol ( TC) concentration (mg/dl)	Evaluate the impact of nutritional intervention on Total Cholesterol ( TC) (mg/dl) between the 0th and 12th month.	12 months
Primary	LDL Cholesterol (LDL-C) concentration (mg/dl)	Evaluate the impact of nutritional intervention on LDL Cholesterol (LDL-C) (mg/dl) between the 0th and 12th month.	12 months
Primary	HDL Cholesterol (HDL-C) concentration (mg/dl)	Evaluate the impact of nutritional intervention on HDL Cholesterol (HDL-C)(mg/dl) between the 0th and 12th month.	12 months
Primary	Triglycerides concentration (mg/dl)	Evaluate the impact of nutritional intervention on Triglycerides(mg/dl) between the 0th and 12th month.	12 months
Primary	Systolic Blood Pressure (SBP) (mmHg)	Evaluate the impact of nutritional intervention on Systolic Blood Pressure (SBP) (mmHg) between the 0th and 12th month.	12 months
Primary	Diastolic Blood Pressure (DBP) (mmHg)	Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.	12 months
Primary	Heart Rate (HR) beats per minute (bpm)	Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.	12 months
Secondary	Skipping breakfast (yes or no)	Observe changes in breakfast skipping habits between the 0th and 12th month.This qualitative variation will be measured by the standard protocol of conventional clinical nutritional analysis, using the metric of (yes or no). Individuals who report "yes" will be considered to have skipped breakfast and individuals who report "no" will be considered to have not skipped breakfast.	12 months
Secondary	Sleep duration (hours) (more than 6 hours or less than 6 hours)	Observe changes in sleep duration (h) between the 0th and 12th month. This qualitative variation will be measured by the standard protocol of conventional clinical nutritional analysis, using the metric of (more than 6h or less than 6h of sleep). Individuals who report ">6" will be considered to have slept more than 6 hours per night and individuals who report "<6" will be considered to have slept less than 6 hours per night.	12 months
Secondary	Night awakenings (amount/ number)	Observe changes in night awakenings between the 0th and 12th month. This qualitative variation will be measured by the standard protocol of conventional clinical nutritional analysis, using the metric of (more than 1 nighttime awakening or no nighttime awakenings). Individuals who report ">1" will be considered to have 1 or more awakenings and individuals who report "0" will be considered to have not awakened during sleep.	12 months
Secondary	Physical activity level (sedentary, moderate, advanced)	Observe changes in Physical activity level between the 0th and 12th month. The presence or absence of physical exercise will be assessed through nutritional history. Patients with levels equal to or greater than 5 training sessions per week, with a total duration of 250 minutes/week, were considered very active/advanced. Patients with levels equal to or greater than 3 training sessions per week, with a total duration of 150 minutes/week, were considered active/moderate. Individuals below this recommendation were considered sedentary.	12 months