Diabetes Mellitus, Type 2NCT04958980
Multiprofessional Approach in Diabetes Mellitus
A study testing Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research in people with Diabetes Mellitus, Type 2, run by Leonardo Paroche de Matos.
Trial summary
OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multiprofessional role in the control of diabetes mellitus in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Mar 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 24 on-insulin-dependent type II diabetes patients (users of oral hypoglycemic agents),
- over 18 years of age,
- both sexes,
- with no restrictions on physical exercise (found after medical evaluation)
- who agreed to participate voluntarily in the study (after signature of the Free and Informed Consent Form)
- of a specific area of the Family Health Strategy - chosen by the proximity to the Basic Health Unit.
Who cannot join
- Patients with associated pathologies: cardiovascular conditions: Congestive Heart Failure,Decompensated Systemic Arterial Hypertension, Sequela of Acute Myocardial Infarction
- Cancer patients,
- Respiratory conditions: Chronic Obstructive Pulmonary Disease, Severe asthma and any other disabling lung condition.
- Endocrine conditions that aggravate diabetes mellitus: Pancreatic pathologies (pancreatitis, pancreatic cysts, obstructions and pancreatic cancer)
- Patients with impaired vision,
- Motor or balance disorders,
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- With any special needs (physical or intellectual),
- With consequences resulting from the evolution of type II diabetes mellitus
- Users who refused to participate in the research.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of the Multiprofessional Approach in an Educational Group in the Control of Diabetes Mellitus in Patients Using Oral Hypoglycemic Agents From a Basic Health Unit in the City of Guarulhos/ SP: a Randomized Study
OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multiprofessional role in the control of diabetes mellitus in adults. METHODOLOGY: a randomized clinical study carried out in an educational group at the Basic Health Unit Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users in the control group and 12 users in the control group. study (which will receive the interventions of the multidisciplinary team) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of the multidisciplinary action in the control of diabetes mellitus.
Read the detailed description
INTRODUCTION: diabetes mellitus is highlighted as an obstacle in health equipment because it is a chronic disease and has a high mortality rate. The pathology results in hyperglycemia, disorders or insufficiency of several organs. OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multidisciplinary role in the control of diabetes mellitus in adults. THEORETICAL BACKGROUND: type II diabetes mellitus (type II DM) is a pathology that represents a high risk for cardiovascular, renal, ophthalmological complications and in several other systems. It is considered a major issue to be controlled by health services, as the high cost of treatments related to the sequelae of type II DM, as well as high rates of hospitalizations and associated therapies have been increasing and decompensating public budgets. Primary care has a fundamental role in preventing the disease and associated complications. METHODOLOGY: randomized clinical study conducted in an educational group at the Basic Health Unit Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users in the control group and 12 users in the group study (which will receive the interventions of the multidisciplinary team) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of the multidisciplinary performance in the control of diabetes mellitus. RESULTS: the participants are expected to show improvements in the control of the pathology and awareness about the relevance of self-care, facts that will be observed through laboratory data and subsequent multi-professional evaluations.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research
- Keywords
- Diabetes mellitus, Health education, Multiprofessional team, Collective health, Health promotion
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the researchBehavioural
Physician: Guidance on pathology, sequelae and treatment, as well as guidance on the importance of medical monitoring.
Dental surgeon: guidance on oral health, demonstration of brushing techniques and daily flossing and periodontal changes resulting from diabetes mellitus.
Nurse: Guidance on pathology prioritizing pathophysiology, self-care and skin care and wound prevention (vascular sequelae).
Nutritionist: nutritional guidelines on diabetes mellitus and healthy eating habits.
Physiotherapist: guidance on prevention of falls and injuries and health promotion.
Physical educator: guidance on the importance of practicing physical activities for general health, encouraging self-care and body awareness and demonstrating basic physical activities that can be performed at home.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | The control group will be evaluated in 2 stages: at the beginning and at the end of the study and will be accompanied only with scheduled medical consultations (also simulating the reality of basic health units with a traditional model of care) and the intervention group will undergo evaluations with the multiprofessional team on two occasions (at the beginning and at the end of the study) |
| Specific and educational guidelines on pathology care (diabetes mellitus) | Active comparator | Multiprofessional educational guidelines and analysis of the following exams:
* Periodontal record, bleeding rate on and visible plaque;
* Body mass index (BMI): weight (kg) divided by height squared (m²);
* Serum glucose values;
* Glycated hemoglobin;
* Blood count: hemoglobin;
* Urea: male:
* Creatinine male;
* Uric acid;
* Oxalacetic glutamic transaminase;
* Glutamic pyruvic transaminase;
* Total cholesterol and fractions: Cholesterol, Non HDL, LDL, VLDL;
* Triglycerides;
* Type I urine;
* Vitamin D3 25OH;
* Microalbuminuria;
* Blood pressure: systolic;
* Abdominal circumference. Receives: Behavioral: Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of periodontitis associated with diabetes mellitus
Periodontal record: up to 3mm.
Measured: 6 months
Risk rate for periodontal disease (in %) associated with diabetes mellitus
Bleeding rate on and visible plaque: up to 10%;
Measured: 6 months
Association of glycemic control with changes in body weight (in kg)
Body mass index (BMI): weight (kg) divided by height squared (m²);
Measured: 6 months
Comparison of glycemic control
Serum glucose values: 80 to 130mg/ dl
Measured: 6 months
% of participants at risk for worsening diabetes mellitus
Glycated hemoglobin: <7%
Measured: 6 months
% of participants at risk for anemic diseases
Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
Measured: 6 months
Concentration of participants at risk for developing kidney complications [urea]
Urea: male: <40mg/ dl, female: <55mg/ dl
Measured: 6 months
Concentration of participants at risk of developing kidney failure
Creatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl
Measured: 6 months
Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus
Uric acid: male: 3.4- 7.0mg/ dl, female: 2.4- 7.4mg/ dl
Measured: 6 months
Concentration of participants at risk for the development of liver complications
Oxalacetic glutamic transaminase: male: <50U/ L, female: <40U/ L
Measured: 6 months
Concentration of participants at risk for the development of liver failure associated with diabetes mellitus
Glutamic pyruvic transaminase: male: <50U/ L, female: <40U/ L
Measured: 6 months
Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus
Total cholesterol and fractions: Cholesterol: 190mg/ dl, HDL:> 40mg/ dl, Non HDL: <160mg/ dl, LDL: <100mg/ dl, VLDL: 10- 50mg/ dl
Measured: 6 months
Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
Triglycerides: <175mg/ dl
Measured: 6 months
Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus
Type I urine: negative proteinuria and glycosuria
Measured: 6 months
Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency
Vitamin D3 25OH: <60y: >20ng/ dl, >60y: >30ng/dl
Measured: 6 months
Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
Microalbuminuria: <30mg/day
Measured: 6 months
Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
Blood pressure: systolic- <130mmHg, diastolic: <85mHg
Measured: 6 months
Concentration of participants at increased risk for diabetes complications related to increased waist circumference
Abdominal circumference: male: 102cm, female: 88cm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical study conducted in an educational group at the Basic Health Unit of Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users of the control group and 12 users of the study group (who will receive the researchers' interventions) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of multiprofessional action in the control of diabetes mellitus.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Paroche de Matos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Paroche de Matos, Leonardo Paroche de Matos
- Investigators
- Lilian Oliveira, Principal investigator, Guarulhos City Hall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958980
- Sponsor's protocol ID
- 00129122020
- Status last verified
- Jul 2021
- First submitted
- 29 Dec 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Multiprofessional Approach in an Educational Group in the Control of Diabetes Mellitus in Patients Using Oral Hypoglycemic Agents From a Basic Health Unit in the City of Guarulhos/ SP: a Randomized Study
- ClinicalTrials.gov ID
- NCT04958980
- Acronym / sponsor ID
- 00129122020
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus, Health education, Multiprofessional team, Collective health, Health promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Leonardo Paroche de MatosUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multiprofessional role in the control of diabetes mellitus in adults. METHODOLOGY: a randomized clinical study carried out in an educational group at the Basic Health Unit Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users in the control group and 12 users in the control group. study (which will receive the interventions of the multidisciplinary team) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of the multidisciplinary action in the control of diabetes mellitus.
Detailed description
INTRODUCTION: diabetes mellitus is highlighted as an obstacle in health equipment because it is a chronic disease and has a high mortality rate. The pathology results in hyperglycemia, disorders or insufficiency of several organs. OBJECTIVE: to verify the effectiveness of adopting the practice of educational groups in primary care and the multidisciplinary role in the control of diabetes mellitus in adults. THEORETICAL BACKGROUND: type II diabetes mellitus (type II DM) is a pathology that represents a high risk for cardiovascular, renal, ophthalmological complications and in several other systems. It is considered a major issue to be controlled by health services, as the high cost of treatments related to the sequelae of type II DM, as well as high rates of hospitalizations and associated therapies have been increasing and decompensating public budgets. Primary care has a fundamental role in preventing the disease and associated complications. METHODOLOGY: randomized clinical study conducted in an educational group at the Basic Health Unit Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users in the control group and 12 users in the group study (which will receive the interventions of the multidisciplinary team) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of the multidisciplinary performance in the control of diabetes mellitus. RESULTS: the participants are expected to show improvements in the control of the pathology and awareness about the relevance of self-care, facts that will be observed through laboratory data and subsequent multi-professional evaluations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized clinical study conducted in an educational group at the Basic Health Unit of Nova Bonsucesso with six monthly meetings scheduled with 24 patients with type II diabetes mellitus users of oral hypoglycemic agents divided into two subgroups: 12 users of the control group and 12 users of the study group (who will receive the researchers' interventions) and will be accompanied by laboratory tests and individual evaluations to verify the effectiveness of multiprofessional action in the control of diabetes mellitus.
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –The control group will be evaluated in 2 stages: at the beginning and at the end of the study and will be accompanied only with scheduled medical consultations (also simulating the reality of basic health units with a traditional model of care) and the intervention group will undergo evaluations with the multiprofessional team on two occasions (at the beginning and at the end of the study) |
| Specific and educational guidelines on pathology care (diabetes mellitus) | Active comparator | Behavioral: Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the researchMultiprofessional educational guidelines and analysis of the following exams: * Periodontal record, bleeding rate on and visible plaque; * Body mass index (BMI): weight (kg) divided by height squared (m²); * Serum glucose values; * Glycated hemoglobin; * Blood count: hemoglobin; * Urea: male: * Creatinine male; * Uric acid; * Oxalacetic glutamic transaminase; * Glutamic pyruvic transaminase; * Total cholesterol and fractions: Cholesterol, Non HDL, LDL, VLDL; * Triglycerides; * Type I urine; * Vitamin D3 25OH; * Microalbuminuria; * Blood pressure: systolic; * Abdominal circumference. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 24 on-insulin-dependent type II diabetes patients (users of oral hypoglycemic agents),
- over 18 years of age,
- both sexes,
- with no restrictions on physical exercise (found after medical evaluation)
- who agreed to participate voluntarily in the study (after signature of the Free and Informed Consent Form)
Key exclusion criteria (9 listed)
- Patients with associated pathologies: cardiovascular conditions: Congestive Heart Failure,Decompensated Systemic Arterial Hypertension, Sequela of Acute Myocardial Infarction
- Cancer patients,
- Respiratory conditions: Chronic Obstructive Pulmonary Disease, Severe asthma and any other disabling lung condition.
- Endocrine conditions that aggravate diabetes mellitus: Pancreatic pathologies (pancreatitis, pancreatic cysts, obstructions and pancreatic cancer)
- Patients with impaired vision,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the researchPhysician: Guidance on pathology, sequelae and treatment, as well as guidance on the importance of medical monitoring. Dental surgeon: guidance on oral health, demonstration of brushing techniques and daily flossing and periodontal changes resulting from diabetes mellitus. Nurse: Guidance on pathology prioritizing pathophysiology, self-care and skin care and wound prevention (vascular sequelae). Nutritionist: nutritional guidelines on diabetes mellitus and healthy eating habits. Physiotherapist: guidance on prevention of falls and injuries and health promotion. Physical educator: guidance on the importance of practicing physical activities for general health, encouraging self-care and body awareness and demonstrating basic physical activities that can be performed at home. | Behavioural | Specific and educational guidelines on pathology care (diabetes mellitus) |
Primary outcome
incidence of periodontitis associated with diabetes mellitus
Time frame: 6 months
Periodontal record: up to 3mm.
Risk rate for periodontal disease (in %) associated with diabetes mellitus
Time frame: 6 months
Bleeding rate on and visible plaque: up to 10%;
Association of glycemic control with changes in body weight (in kg)
Time frame: 6 months
Body mass index (BMI): weight (kg) divided by height squared (m²);
Comparison of glycemic control
Time frame: 6 months
Serum glucose values: 80 to 130mg/ dl
% of participants at risk for worsening diabetes mellitus
Time frame: 6 months
Glycated hemoglobin: <7%
% of participants at risk for anemic diseases
Time frame: 6 months
Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
Concentration of participants at risk for developing kidney complications [urea]
Time frame: 6 months
Urea: male: <40mg/ dl, female: <55mg/ dl
Concentration of participants at risk of developing kidney failure
Time frame: 6 months
Creatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl
Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus
Time frame: 6 months
Uric acid: male: 3.4- 7.0mg/ dl, female: 2.4- 7.4mg/ dl
Concentration of participants at risk for the development of liver complications
Time frame: 6 months
Oxalacetic glutamic transaminase: male: <50U/ L, female: <40U/ L
Concentration of participants at risk for the development of liver failure associated with diabetes mellitus
Time frame: 6 months
Glutamic pyruvic transaminase: male: <50U/ L, female: <40U/ L
Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus
Time frame: 6 months
Total cholesterol and fractions: Cholesterol: 190mg/ dl, HDL:> 40mg/ dl, Non HDL: <160mg/ dl, LDL: <100mg/ dl, VLDL: 10- 50mg/ dl
Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
Time frame: 6 months
Triglycerides: <175mg/ dl
Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus
Time frame: 6 months
Type I urine: negative proteinuria and glycosuria
Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency
Time frame: 6 months
Vitamin D3 25OH: <60y: >20ng/ dl, >60y: >30ng/dl
Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
Time frame: 6 months
Microalbuminuria: <30mg/day
Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
Time frame: 6 months
Blood pressure: systolic- <130mmHg, diastolic: <85mHg
Concentration of participants at increased risk for diabetes complications related to increased waist circumference
Time frame: 6 months
Abdominal circumference: male: 102cm, female: 88cm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian Oliveira principal investigator
Guarulhos City Hall
Questions about this trial
What is this clinical trial studying?
A study testing Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research in people with Diabetes Mellitus, Type 2, run by Leonardo Paroche de Matos.
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 9 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Matos (5511988000176, leonardoparoche@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of periodontitis associated with diabetes mellitus (time frame: 6 months). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.