Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Usual Diet Guidance; Other: Nutritional Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02488213

14-0585

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Usual Diet Guidance

Active Comparator group

Description:

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.

Treatment:

Other: Usual Diet Guidance

Nutritional Counseling

Experimental group

Description:

The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material.

Treatment:

Other: Nutritional Counseling