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Multiprofessional Approach in Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research
Sponsored by
Leonardo Paroche de Matos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, Health education, Multiprofessional team, Collective health, Health promotion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Placebo

    Specific and educational guidelines on pathology care (diabetes mellitus)

    Arm Description

    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)

    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.

    Outcomes

    Primary Outcome Measures

    incidence of periodontitis associated with diabetes mellitus
    Periodontal record: up to 3mm.
    Risk rate for periodontal disease (in %) associated with diabetes mellitus
    Bleeding rate on and visible plaque: up to 10%;
    Association of glycemic control with changes in body weight (in kg)
    Body mass index (BMI): weight (kg) divided by height squared (m²);
    Comparison of glycemic control
    Serum glucose values: 80 to 130mg/ dl
    % of participants at risk for worsening diabetes mellitus
    Glycated hemoglobin: <7%
    % of participants at risk for anemic diseases
    Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
    Concentration of participants at risk for developing kidney complications [urea]
    Urea: male: <40mg/ dl, female: <55mg/ dl
    Concentration of participants at risk of developing kidney failure
    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
    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
    Oxalacetic glutamic transaminase: male: <50U/ L, female: <40U/ L
    Concentration of participants at risk for the development of liver failure associated with diabetes mellitus
    Glutamic pyruvic transaminase: male: <50U/ L, female: <40U/ L
    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
    Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
    Triglycerides: <175mg/ dl
    Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus
    Type I urine: negative proteinuria and glycosuria
    Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency
    Vitamin D3 25OH: <60y: >20ng/ dl, >60y: >30ng/dl
    Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
    Microalbuminuria: <30mg/day
    Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
    Blood pressure: systolic- <130mmHg, diastolic: <85mHg
    Concentration of participants at increased risk for diabetes complications related to increased waist circumference
    Abdominal circumference: male: 102cm, female: 88cm

    Secondary Outcome Measures

    Full Information

    First Posted
    December 29, 2020
    Last Updated
    July 11, 2021
    Sponsor
    Leonardo Paroche de Matos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04958980
    Brief Title
    Multiprofessional Approach in Diabetes Mellitus
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Leonardo Paroche de Matos

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Diabetes mellitus, Health education, Multiprofessional team, Collective health, Health promotion

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Masking Description
    The formation of randomized groups will occur by random drawing, obeying the proportion of 1: 1 in both groups, that is, 12 participants in each group (control and intervention) that will be selected after the screening carried out by the research nurse (to verify some possible exclusion criteria for research participants), reducing the occurrence of methodological bias in the sampling phase and ensuring the possibility that all participants can be included in the intervention group.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    No Intervention
    Arm Description
    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)
    Arm Title
    Specific and educational guidelines on pathology care (diabetes mellitus)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    incidence of periodontitis associated with diabetes mellitus
    Description
    Periodontal record: up to 3mm.
    Time Frame
    6 months
    Title
    Risk rate for periodontal disease (in %) associated with diabetes mellitus
    Description
    Bleeding rate on and visible plaque: up to 10%;
    Time Frame
    6 months
    Title
    Association of glycemic control with changes in body weight (in kg)
    Description
    Body mass index (BMI): weight (kg) divided by height squared (m²);
    Time Frame
    6 months
    Title
    Comparison of glycemic control
    Description
    Serum glucose values: 80 to 130mg/ dl
    Time Frame
    6 months
    Title
    % of participants at risk for worsening diabetes mellitus
    Description
    Glycated hemoglobin: <7%
    Time Frame
    6 months
    Title
    % of participants at risk for anemic diseases
    Description
    Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
    Time Frame
    6 months
    Title
    Concentration of participants at risk for developing kidney complications [urea]
    Description
    Urea: male: <40mg/ dl, female: <55mg/ dl
    Time Frame
    6 months
    Title
    Concentration of participants at risk of developing kidney failure
    Description
    Creatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl
    Time Frame
    6 months
    Title
    Concentration of participants at risk for the development of kidney stones and worsening of diabetes mellitus
    Description
    Uric acid: male: 3.4- 7.0mg/ dl, female: 2.4- 7.4mg/ dl
    Time Frame
    6 months
    Title
    Concentration of participants at risk for the development of liver complications
    Description
    Oxalacetic glutamic transaminase: male: <50U/ L, female: <40U/ L
    Time Frame
    6 months
    Title
    Concentration of participants at risk for the development of liver failure associated with diabetes mellitus
    Description
    Glutamic pyruvic transaminase: male: <50U/ L, female: <40U/ L
    Time Frame
    6 months
    Title
    Observation of the risk of developing cardiovascular diseases associated with diabetes mellitus
    Description
    Total cholesterol and fractions: Cholesterol: 190mg/ dl, HDL:> 40mg/ dl, Non HDL: <160mg/ dl, LDL: <100mg/ dl, VLDL: 10- 50mg/ dl
    Time Frame
    6 months
    Title
    Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
    Description
    Triglycerides: <175mg/ dl
    Time Frame
    6 months
    Title
    Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus
    Description
    Type I urine: negative proteinuria and glycosuria
    Time Frame
    6 months
    Title
    Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency
    Description
    Vitamin D3 25OH: <60y: >20ng/ dl, >60y: >30ng/dl
    Time Frame
    6 months
    Title
    Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
    Description
    Microalbuminuria: <30mg/day
    Time Frame
    6 months
    Title
    Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
    Description
    Blood pressure: systolic- <130mmHg, diastolic: <85mHg
    Time Frame
    6 months
    Title
    Concentration of participants at increased risk for diabetes complications related to increased waist circumference
    Description
    Abdominal circumference: male: 102cm, female: 88cm
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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, 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leonardo Matos
    Phone
    5511988000176
    Email
    leonardoparoche@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lilian Oliveira
    Organizational Affiliation
    Guarulhos City Hall
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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