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

January 29, 2024 updated by: Tatiana Palotta Minari, Sao Jose do Rio Preto Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Faculty of Medicine in São José do Rio Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional Medical Evaluation
Participants in the control group will only undergo conventional medical evaluation.
Active Comparator: Conventional Medical Evaluation Plus Nutritional Assessment
Participants in the intervention group will undergo the same medical care, concomitantly with nutritional assessment.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight (kg)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on weight (kg) between the 0th and 12th month.
12 months
Body Mass Index (kg/m²).
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Body Mass Index (kg/m²) between the 0th and 12th month.
12 months
Waist circumference (cm)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Waist circumference (cm) between the 0th and 12th month.
12 months
Waist Hip Ratio (WHR) [Waist circumference (cm)/hip circumference(cm)]
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Waist Hip Ratio (WHR) between the 0th and 12th month.
12 months
fasting blood glucose concentration (mg/dl)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Fasting blood glucose (mg/dl) between the 0th and 12th month.
12 months
glycated hemoglobin (HBA1C) rates (%)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Glycated Hemoglobin (HBA1C) (%) between the 0th and 12th month.
12 months
Total Cholesterol ( TC) concentration (mg/dl)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Total Cholesterol ( TC) (mg/dl) between the 0th and 12th month.
12 months
LDL Cholesterol (LDL-C) concentration (mg/dl)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on LDL Cholesterol (LDL-C) (mg/dl) between the 0th and 12th month.
12 months
HDL Cholesterol (HDL-C) concentration (mg/dl)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on HDL Cholesterol (HDL-C)(mg/dl) between the 0th and 12th month.
12 months
Triglycerides concentration (mg/dl)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Triglycerides(mg/dl) between the 0th and 12th month.
12 months
Systolic Blood Pressure (SBP) (mmHg)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Systolic Blood Pressure (SBP) (mmHg) between the 0th and 12th month.
12 months
Diastolic Blood Pressure (DBP) (mmHg)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.
12 months
Heart Rate (HR) beats per minute (bpm)
Time Frame: 12 months
Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skipping breakfast (yes or no)
Time Frame: 12 months
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
Sleep duration (hours) (more than 6 hours or less than 6 hours)
Time Frame: 12 months
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
Night awakenings (amount/ number)
Time Frame: 12 months
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
Physical activity level (sedentary, moderate, advanced)
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sao Jose do Rio Preto Medical School

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Tatiana Palotta Minari, PhD Student, State Faculty of Medicine in São José do Rio Preto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2020

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33554520.0.0000.5415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in nutritional strategies for the management of type 2 diabetes mellitus. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact:

tatianaminari@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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