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

NCT06235762 | Completed

• 1 other identifier: 33554520.0.0000.5415
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (13)

• Weight (kg)

  Evaluate the impact of nutritional intervention on weight (kg) between the 0th and 12th month.

  12 months

• 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

• Waist circumference (cm)

  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)]

  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)

  Evaluate the impact of nutritional intervention on Fasting blood glucose (mg/dl) between the 0th and 12th month.

  12 months

• glycated hemoglobin (HBA1C) rates (%)

  Evaluate the impact of nutritional intervention on Glycated Hemoglobin (HBA1C) (%) between the 0th and 12th month.

  12 months

• 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

• 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

• 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

• Triglycerides concentration (mg/dl)

  Evaluate the impact of nutritional intervention on Triglycerides(mg/dl) between the 0th and 12th month.

  12 months

• 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

• 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

• 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 Outcomes (4)

• Skipping breakfast (yes or no)

  12 months

• Sleep duration (hours) (more than 6 hours or less than 6 hours)

  12 months

• Night awakenings (amount/ number)

  12 months

• Physical activity level (sedentary, moderate, advanced)

  12 months

Study Arms (2)

Conventional Medical Evaluation

NO INTERVENTION

Participants in the control group will only undergo conventional medical evaluation.

Conventional Medical Evaluation Plus Nutritional Assessment

ACTIVE COMPARATOR

Participants in the intervention group will undergo the same medical care, concomitantly with nutritional assessment.

Behavioral: Nutritional Intervention

Interventions

Nutritional Intervention BEHAVIORAL

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

Conventional Medical Evaluation Plus Nutritional Assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sao Jose do Rio Preto Medical School: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Faculty of Medicine in São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypertension; COVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tatiana Palotta Minari, PhD Student

  State Faculty of Medicine in São José do Rio Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Ranzomized Clinical Trial

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 1, 2024
• Study Start: August 16, 2020
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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

Locations

BR (1)