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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Usual Diet Guidance; Other: Nutritional Counseling

• Registration Number: NCT02488213
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Diet Guidance	Usual Diet Guidance	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	Nutritional Counseling	The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material.

Primary Outcome Measures

Name	Time	Method
Glicemic control	six months	Obtaining HbA1c \<7% and/or reduction in HbA1c at least 1% of baseline

Secondary Outcome Measures

Name	Time	Method
Obtaining therapeutic target	six months	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.
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.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil