- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958980
Multiprofessional Approach in Diabetes Mellitus
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 Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leonardo Matos
- Phone Number: 5511988000176
- Email: leonardoparoche@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Placebo
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)
|
|
Active Comparator: Specific and educational guidelines on pathology care (diabetes mellitus)
Multiprofessional educational guidelines and analysis of the following exams:
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of periodontitis associated with diabetes mellitus
Time Frame: 6 months
|
Periodontal record: up to 3mm.
|
6 months
|
Risk rate for periodontal disease (in %) associated with diabetes mellitus
Time Frame: 6 months
|
Bleeding rate on and visible plaque: up to 10%;
|
6 months
|
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);
|
6 months
|
Comparison of glycemic control
Time Frame: 6 months
|
Serum glucose values: 80 to 130mg/ dl
|
6 months
|
% of participants at risk for worsening diabetes mellitus
Time Frame: 6 months
|
Glycated hemoglobin: <7%
|
6 months
|
% of participants at risk for anemic diseases
Time Frame: 6 months
|
Blood count: hemoglobin: male 13-17g/ dl, female: 12 -15g/ dl
|
6 months
|
Concentration of participants at risk for developing kidney complications [urea]
Time Frame: 6 months
|
Urea: male: <40mg/ dl, female: <55mg/ dl
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Concentration of participants at risk for the development of liver complications
Time Frame: 6 months
|
Oxalacetic glutamic transaminase: male: <50U/ L, female: <40U/ L
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Observation of triglyceride rates and the development of risk for cardiovascular complications associated with diabetes mellitus
Time Frame: 6 months
|
Triglycerides: <175mg/ dl
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Observation of the risk of developing nephropathies, retinopathies and cardiovascular diseases associated with diabetes mellitus
Time Frame: 6 months
|
Microalbuminuria: <30mg/day
|
6 months
|
Concentration of participants at risk of developing systemic arterial hypertension associated with diabetes mellitus
Time Frame: 6 months
|
Blood pressure: systolic- <130mmHg, diastolic: <85mHg
|
6 months
|
Concentration of participants at increased risk for diabetes complications related to increased waist circumference
Time Frame: 6 months
|
Abdominal circumference: male: 102cm, female: 88cm
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lilian Oliveira, Guarulhos City Hall
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00129122020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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