Type 2 Diabetes Mellitus
Conditions
Keywords
Nutritional Counseling, Diet
Brief summary
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.
Detailed description
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.
Interventions
OTHERNutritional Counseling
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.
OTHERUsual Diet Guidance
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.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes patients aged ≥ 30 years; * Body mass index ≤ 40kg/m²; * Serum creatinine \<2 mg/dL; * Serum triglycerides \<400 mg/dL.
Exclusion criteria
* Cognitive impairment (clinical suspicion); * Illiterate; * Liver function tests and abnormal thyroid; * Urinary tract infection carriers, kidney disease and heart failure uncompensated (grade III or IV); * Active wasting disease diagnosis (Cancer, Acquired Immune Deficiency Syndrome); * Metabolic control within the therapeutic target; * Patients with dietary guidance by nutritionist in less than three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glicemic control | six months | Obtaining HbA1c \<7% and/or reduction in HbA1c at least 1% of baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obtaining therapeutic target | six months | Obtaining therapeutic target from laboratory evaluation: fasting blood glucose of 70 to 130mg/dL (serum measurement) |
| Adherence to nutritional counseling | six months | 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. |
Countries
Brazil
Contacts
Primary ContactJuliana P Antonio
Outcome results
None listed