Multiprofessional Approach in Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04958980
• Other study ID #: 00129122020
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: March 2022

Study information

• Verified date: July 2021
• Source: Leonardo Paroche de Matos
• Contact: Leonardo Matos
• Phone: 5511988000176
• Email: leonardoparoche[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leonardo Paroche de Matos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of periodontitis associated with diabetes mellitus	Periodontal record: up to 3mm.	6 months
Primary	Risk rate for periodontal disease (in %) associated with diabetes mellitus	Bleeding rate on and visible plaque: up to 10%;	6 months
Primary	Association of glycemic control with changes in body weight (in kg)	Body mass index (BMI): weight (kg) divided by height squared (m²);	6 months
Primary	Comparison of glycemic control	Serum glucose values: 80 to 130mg/ dl	6 months
Primary	% of participants at risk for worsening diabetes mellitus	Glycated hemoglobin: <7%	6 months
Primary	% of participants at risk for anemic diseases	Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl	6 months
Primary	Concentration of participants at risk for developing kidney complications [urea]	Urea: male: <40mg/ dl, female: <55mg/ dl	6 months
Primary	Concentration of participants at risk of developing kidney failure	Creatinine male: 0.7-1.30mg/ dl, female: 0.5- 1.10mg/ dl	6 months
Primary	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	6 months
Primary	Concentration of participants at risk for the development of liver complications	Oxalacetic glutamic transaminase: male: <50U/ L, female: <40U/ L	6 months
Primary	Concentration of participants at risk for the development of liver failure associated with diabetes mellitus	Glutamic pyruvic transaminase: male: <50U/ L, female: <40U/ L	6 months
Primary	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	6 months
Primary	Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus	Triglycerides: <175mg/ dl	6 months
Primary	Concentration of participants with renal complications and urinary glucose and protein elimination associated with diabetes mellitus	Type I urine: negative proteinuria and glycosuria	6 months
Primary	Concentration of participants at increased risk for diabetes complications related to vitamin D deficiency	Vitamin D3 25OH: <60y: >20ng/ dl, >60y: >30ng/dl	6 months
Primary	Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus	Microalbuminuria: <30mg/day	6 months
Primary	Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus	Blood pressure: systolic- <130mmHg, diastolic: <85mHg	6 months
Primary	Concentration of participants at increased risk for diabetes complications related to increased waist circumference	Abdominal circumference: male: 102cm, female: 88cm	6 months