Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nutritional Counseling
Usual Diet Guidance
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Nutritional Counseling, Diet
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.
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Diet Guidance
Nutritional Counseling
Arm 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.
The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material.
Outcomes
Primary Outcome Measures
Glicemic control
Obtaining HbA1c <7% and/or reduction in HbA1c at least 1% of baseline
Secondary Outcome Measures
Obtaining therapeutic target
Obtaining therapeutic target from laboratory evaluation: fasting blood glucose of 70 to 130mg/dL (serum measurement)
Obtaining therapeutic target
Obtaining therapeutic target from laboratory evaluation: LDL cholesterol <100mg/dL (serum measurement)
Obtaining therapeutic target
Obtaining therapeutic target from laboratory evaluation: triglycerides <150mg/dL (serum measurement)
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.
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.
Full Information
NCT ID
NCT02488213
First Posted
March 9, 2015
Last Updated
August 24, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02488213
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Nutritional Counseling, Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Diet Guidance
Arm Type
Active Comparator
Arm 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.
Arm Title
Nutritional Counseling
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Nutritional Counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Diet Guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glicemic control
Description
Obtaining HbA1c <7% and/or reduction in HbA1c at least 1% of baseline
Time Frame
six months
Secondary Outcome Measure Information:
Title
Obtaining therapeutic target
Description
Obtaining therapeutic target from laboratory evaluation: fasting blood glucose of 70 to 130mg/dL (serum measurement)
Time Frame
six months
Title
Obtaining therapeutic target
Description
Obtaining therapeutic target from laboratory evaluation: LDL cholesterol <100mg/dL (serum measurement)
Time Frame
six months
Title
Obtaining therapeutic target
Description
Obtaining therapeutic target from laboratory evaluation: triglycerides <150mg/dL (serum measurement)
Time Frame
six months
Title
Obtaining therapeutic target
Description
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.
Time Frame
six months
Title
Adherence to nutritional counseling
Description
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.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana P Antonio
Phone
+ 55 51 3359 8530
Email
juantonio@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jussara C de Almeida
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana P Antonio
Phone
+ 55 51 3359 8530
Email
juantonio@hcpa.edu.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus
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