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Diabetes Mellitus Type 2NCT06235762

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

A study testing Nutritional Intervention in people with Diabetes Mellitus Type 2 and Diabetes Mellitus Type 2 in Obese, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Nutritional Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteBrazil
Study dates
16 Aug 2020to 15 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faculty of Medicine in São José do Rio Preto

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

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Nutritional Intervention
Keywords
Type 2 Diabetes Mellitus, Nutritional intervention, Nutrition, Nutritional Strategy, COVID-19, Mediterranean Diet, DASH Diet
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypertension, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional InterventionBehavioural

    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

Study groups in NCT06235762
Study groupRoleWhat they receive
Conventional Medical EvaluationNo interventionParticipants in the control group will only undergo conventional medical evaluation.
Conventional Medical Evaluation Plus Nutritional AssessmentActive comparatorParticipants in the intervention group will undergo the same medical care, concomitantly with nutritional assessment.
Receives: Behavioral: Nutritional Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight (kg)

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

    Measured: 12 months

  2. Body Mass Index (kg/m²).

    Evaluate the impact of nutritional intervention on Body Mass Index (kg/m²) between the 0th and 12th month.

    Measured: 12 months

  3. Waist circumference (cm)

    Evaluate the impact of nutritional intervention on Waist circumference (cm) between the 0th and 12th month.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. fasting blood glucose concentration (mg/dl)

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

    Measured: 12 months

  6. glycated hemoglobin (HBA1C) rates (%)

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

    Measured: 12 months

  7. Total Cholesterol ( TC) concentration (mg/dl)

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

    Measured: 12 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 12 months

  10. Triglycerides concentration (mg/dl)

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

    Measured: 12 months

  11. Systolic Blood Pressure (SBP) (mmHg)

    Evaluate the impact of nutritional intervention on Systolic Blood Pressure (SBP) (mmHg) between the 0th and 12th month.

    Measured: 12 months

  12. Diastolic Blood Pressure (DBP) (mmHg)

    Evaluate the impact of nutritional intervention on Diastolic Blood Pressure (DBP) (mmHg) between the 0th and 12th month.

    Measured: 12 months

  13. 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.

    Measured: 12 months

Secondary outcomes (4)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start16 Aug 2020
  3. Primary completion15 Nov 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Ranzomized Clinical Trial
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235762
Sponsor's protocol ID
33554520.0.0000.5415
Status last verified
Jan 2024
First submitted
22 Dec 2023
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Intervention in people with Diabetes Mellitus Type 2 and Diabetes Mellitus Type 2 in Obese, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (kg) (time frame: 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06235762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.

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