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Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients.
Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients. The initial step will be performed analysis of composition and diet quality, and anthropometric and laboratory evaluation. After initial assessment and meeting the criteria eligibility, patients will be randomized to receive nutritional counseling from diet quality (intervention group) or usual diet in according to current nutritional recommendations (control group). Both the groups will receive adjust caloric intake as the nutritional needs of each patient. Patients will be followed over six months, on a monthly basis from hospital visits or telephone monitoring. The outcomes evaluated will be: the achievement of therapeutic targets (fasting blood glucose levels between 70-130 mg / dL, HbA1c<7%, LDL cholesterol <100 mg/dL and triglycerides <150 mg/dL); use of antidiabetic drugs, lipid-lowering and antihypertensive drugs, and adherence to necessary dietary changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Diet Guidance | Active Comparator | The patients will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed in outpatient patients treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. |
|
| Nutritional Counseling | Experimental | The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Counseling | Other | The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months. |
| Measure | Description | Time Frame |
|---|---|---|
| Glicemic control | Obtaining HbA1c <7% and/or reduction in HbA1c at least 1% of baseline | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Obtaining therapeutic target | Obtaining therapeutic target from laboratory evaluation: fasting blood glucose of 70 to 130mg/dL (serum measurement) | six months |
| Obtaining therapeutic target | Obtaining therapeutic target from laboratory evaluation: LDL cholesterol <100mg/dL (serum measurement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana P Antonio | Contact | + 55 51 3359 8530 | juantonio@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Jussara C de Almeida | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Usual Diet Guidance | Other | The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months. |
|
| six months |
| Obtaining therapeutic target | Obtaining therapeutic target from laboratory evaluation: triglycerides <150mg/dL (serum measurement) | six months |
| Obtaining therapeutic target | Obtaining therapeutic target for average blood pressure <130/80 mmHg. There will be two measures separately, with one-minute interval, with the patient seated after five minutes of rest. | six months |
| Adherence to nutritional counseling | Adherence to nutritional counseling will be measured from food surveys, telephone monitoring and implementation of a reliable scale to assess the degree of commitment to nutritional guidelines. | six months |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |