NCT02488213

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Nutritional 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.
OTHER	Usual 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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-07-02
• Last updated: 2016-08-25

Locations

1 site across 1 country: Brazil