- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02488213
Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus
August 24, 2016 updated by: Hospital de Clinicas de Porto Alegre
Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
196
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juliana P Antonio
- Phone Number: + 55 51 3359 8530
- Email: juantonio@hcpa.edu.br
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Juliana P Antonio
- Phone Number: + 55 51 3359 8530
- Email: juantonio@hcpa.edu.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glicemic control
Time Frame: six months
|
Obtaining HbA1c <7% and/or reduction in HbA1c at least 1% of baseline
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obtaining therapeutic target
Time Frame: six months
|
Obtaining therapeutic target from laboratory evaluation: fasting blood glucose of 70 to 130mg/dL (serum measurement)
|
six months
|
Obtaining therapeutic target
Time Frame: six months
|
Obtaining therapeutic target from laboratory evaluation: LDL cholesterol <100mg/dL (serum measurement)
|
six months
|
Obtaining therapeutic target
Time Frame: six months
|
Obtaining therapeutic target from laboratory evaluation: triglycerides <150mg/dL (serum measurement)
|
six months
|
Obtaining therapeutic target
Time Frame: 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.
|
six months
|
Adherence to nutritional counseling
Time Frame: 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.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jussara C de Almeida, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
June 30, 2015
First Posted (Estimate)
July 2, 2015
Study Record Updates
Last Update Posted (Estimate)
August 25, 2016
Last Update Submitted That Met QC Criteria
August 24, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
HighTide Biopharma Pty LtdRecruitingT2DM (Type 2 Diabetes Mellitus)China
Clinical Trials on Usual Diet Guidance
-
First Affiliated Hospital of Zhejiang UniversityUnknownCrohn Disease
-
University of California, San DiegoAmerican Pistachio GrowersCompleted
-
University of PittsburghWithdrawnMetabolic Syndrome | Diet Modification | Prostate Cancer
-
Danish Labor InspectorateNational Research Centre for the Working Environment, DenmarkRecruitingOccupational Diseases | Safety Issues | Occupational InjuriesDenmark
-
University of MalagaUniversidad Católica San Antonio de MurciaCompletedStroke | Intellectual Disability | Acquired Brain Injury | Occupational Therapy | Students | AwarenessSpain
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
Pennington Biomedical Research CenterNot yet recruitingBody Weight | Insulin ResistanceUnited States
-
University College CorkCompletedElevated Blood PressureIreland
-
Purdue UniversityJohns Hopkins University; University of California, San Diego; National Heart... and other collaboratorsTerminated
-
University of VirginiaRecruitingObesity | Food Preferences | Hunger | Ingestive BehaviorUnited States