NCT02488213

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

March 9, 2015

Last Update Submit

August 24, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

Nutritional CounselingDiet

Outcome Measures

Primary Outcomes (1)

  • Glicemic control

    Obtaining HbA1c \<7% and/or reduction in HbA1c at least 1% of baseline

    six months

Secondary Outcomes (5)

  • Obtaining therapeutic target

    six months

  • Obtaining therapeutic target

    six months

  • Obtaining therapeutic target

    six months

  • Obtaining therapeutic target

    six months

  • Adherence to nutritional counseling

    six months

Study Arms (2)

Usual Diet Guidance

ACTIVE COMPARATOR

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.

Other: Usual Diet Guidance

Nutritional Counseling

EXPERIMENTAL

The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material.

Other: Nutritional Counseling

Interventions

Nutritional CounselingOTHER

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.

Nutritional Counseling
Usual Diet GuidanceOTHER

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.

Usual Diet Guidance

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes patients aged ≥ 30 years;
  • Body mass index ≤ 40kg/m²;
  • Serum creatinine \<2 mg/dL;
  • Serum triglycerides \<400 mg/dL.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Jussara C de Almeida

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana P Antonio

CONTACT

+ 55 51 3359 8530juantonio@hcpa.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

July 2, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

BR(1)