Diabetes Mellitus Type 2
Conditions
Keywords
Pharmaceutical Care, Diabetics patients, Clinical trial
Brief summary
The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p \<0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.
Interventions
BEHAVIORALIntervention: Pharmaceutical Care
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
Sponsors
Universidade Federal do Rio Grande do Norte
Universidade Estadual da Paraiba
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: * patients aged 30 years, * diagnosed with type 2 diabetes, * to make use of oral antidiabetic agents with or without insulin
Exclusion criteria
those who had infectious diseases during the research * missed three consecutive interviews, * suspended the hypoglycemic drug and medical order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin | Up to 24 weeks | average glycated hemoglobin over 24 weeks |
| Fasting Glycemia | Up to 24 weeks | average fasting glycemia over 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol | Up to 24 weeks | average total cholesterol over 24 weeks |
| LDL Cholesterol | Up to 24 weeks | average LDL cholesterol over 24 weeks |
Countries
Brazil
Participant flow
Recruitment details
From September 2009 to December 2011.Medical clinic
Pre-assignment details
The exclusion criteria were (i) to have an infectious disease during the study, (ii) to miss three consecutive appointments, (iii) to stop the use of the hypoglycemic drugs by order of the doctor, and (iv) to deny the acceptance of the term of free and informed consent (TFIC).
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice | 47 |
| Control Group Patients will not be followed by the pharmacist. | 42 |
| Total | 89 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 30 Participants | 67 Participants |
| Gender Female | 27 Participants | 22 Participants | 49 Participants |
| Gender Male | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment Brazil | 47 participants | 42 participants | 89 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 42 | 32 / 47 |
| serious Total, serious adverse events | 31 / 42 | 34 / 47 |
Outcome results
Primary
Fasting Glycemia
average fasting glycemia over 24 weeks
Time frame: Up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Fasting Glycemia | 157.7 mg/dL | Standard Deviation 43.1 |
| Intervention Group | Fasting Glycemia | 159.3 mg/dL | Standard Deviation 56.7 |
Primary
Glycated Hemoglobin
average glycated hemoglobin over 24 weeks
Time frame: Up to 24 weeks
Population: Data are glycated hemoglobin means of all patients per group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Glycated Hemoglobin | 7.2 percent (%) | Standard Deviation 1.5 |
| Intervention Group | Glycated Hemoglobin | 7.1 percent (%) | Standard Deviation 1.7 |
Secondary
LDL Cholesterol
average LDL cholesterol over 24 weeks
Time frame: Up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | LDL Cholesterol | 131.0 mg/dL | Standard Deviation 33 |
| Intervention Group | LDL Cholesterol | 110.8 mg/dL | Standard Deviation 32.4 |
Secondary
Total Cholesterol
average total cholesterol over 24 weeks
Time frame: Up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Total Cholesterol | 209.9 mg/dL | Standard Deviation 42.8 |
| Intervention Group | Total Cholesterol | 191.1 mg/dL | Standard Deviation 36.5 |