Clinical trial NCT02488213: Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Nutritional Counseling
Diet
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 196
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glicemic control
timeFrame: six months
Secondary outcomes:
measure: Obtaining therapeutic target
timeFrame: six months
measure: Obtaining therapeutic target
timeFrame: six months
measure: Obtaining therapeutic target
timeFrame: six months
measure: Obtaining therapeutic target
timeFrame: six months
measure: Adherence to nutritional counseling
timeFrame: six months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Jussara C de Almeida
role: PRINCIPAL_INVESTIGATOR
References: