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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02488213
• Other study ID #: 14-0585
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: August 24, 2016
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Juliana P Antonio
• Phone: + 55 51 3359 8530
• Email: juantonio[@]hcpa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glicemic control	Obtaining HbA1c <7% and/or reduction in HbA1c at least 1% of baseline	six months	No
Secondary	Obtaining therapeutic target	Obtaining therapeutic target from laboratory evaluation: fasting blood glucose of 70 to 130mg/dL (serum measurement)	six months	No
Secondary	Obtaining therapeutic target	Obtaining therapeutic target from laboratory evaluation: LDL cholesterol <100mg/dL (serum measurement)	six months	No
Secondary	Obtaining therapeutic target	Obtaining therapeutic target from laboratory evaluation: triglycerides <150mg/dL (serum measurement)	six months	No
Secondary	Obtaining therapeutic target	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.	six months	No
Secondary	Adherence to nutritional counseling	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.	six months	No