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Effect of the Teleconsultation of Renal Nutrition on Renal Function and Glycemic Control in Patients With DKD

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ClinicalTrials.gov Identifier: NCT03344549
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Garcia Contreras, Hospital Civil Juan I. Menchaca

Brief Summary:

The modern era is characterized by progress, development and social and economic globalization. Currently the electronic technology has applications in a wide variety of work areas. A clear example of this, is telemedicine. The technological tools are increasingly used every day in the improvement of the processes and the attention in health, in the last decades, telemedicine has grown exponentially becoming more accessible to the population.

On the other hand, and in the same way, the number of people with chronic degenerative diseases such as diabetes and chronic kidney disease are increasing with alarming numbers, The health system can not offer the attention to the great demand. The strategies used until now for its management have gradually evolved towards a more effective prevention and treatment approach which requires a multidisciplinary team. Investigate the use of new tools that promise to improve the service, has also become a prevailing need. Therefore, the purpose of this study is to know the effect of nutritional teleconsultation on renal function and glycemic control of patients with Diabetic Kidney Disease (DKD) in pre-dialysis stages (specifically G3a, G3b and G4).


Condition or disease Intervention/treatment Phase
Diet Modification Diabetic Kidney Disease Chronic Kidney Diseases Behavioral: Renal nutrition teleconsultation Behavioral: Face-to-face consultation of renal nutrition Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the experimental group, the nutritional intervention will be done through teleconsultation with the free technological tool chosen (the patients from home and the nutritionist from the remote clinic); and in the control group will be offered the nutritional intervention through face-to-face consultations carried out by the nutritionist of the nutrition service of the institution, both arms will be intervened monthly for four months, the duration of the sessions will be 45 minutes and will include evaluation or re-evaluation of dietary data, diagnosis, treatment and educational approach.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nutritional Intervention Through Teleconsultation on Glomerular Filtration Rate and Glycated Hemoglobin A1c in Patients With Diabetic Kidney Disease in Stage G3a, G3b and G4.
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Teleconsultation
In the patients of the experimental group, the nutritional intervention is carried out through teleconsultation with the free technological tool chosen (the patients from home and the nutritionist from the remote clinic).
Behavioral: Renal nutrition teleconsultation
Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
Face-to-face consultation
In the patients of the other group, the nutritional intervention is offered through face-to-face consultations carried out by the nutritionist of the nutrition service of the institution.
Behavioral: Face-to-face consultation of renal nutrition
Face-to-face consultation of renal nutrition for patients with diabetic kidney disease without dialysis, monthly for 4 months.



Primary Outcome Measures :
  1. Know the glycemic control [ Time Frame: Baseline and at 4 month ]
    Determination of the changes in glycated hemoglobin (HbA1c) at the beginning and end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.

  2. Know the renal function [ Time Frame: Baseline and at 4 month ]
    Determination of the changes in the estimated glomerular filtration rate (eGFR), at the beginning and at the end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.


Secondary Outcome Measures :
  1. Adherence to treatment [ Time Frame: Baseline and at 5 month ]
    To know the adherence to the treatment through the evaluation of energy intake and protein at the beginning and after 4 months in both study groups.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diabetic kidney with eGFR <60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively).
  • Patients who can read and write.
  • Patients who have access to the internet and have a computer, tablet or smartphone.
  • Patients who signed the voluntary agreement to participate.

Exclusion Criteria:

  • Patients who have received prior nutritional treatment for the control of diabetic kidney disease.
  • Patients with actual consumption of food supplements and / or keto analogues.
  • Patients with anemia or recent transfusions (in the last 3 months).
  • Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, etc.).
  • Patients with serious difficulties in communication or intellectual deficit that impedes the ability to understand the intervention.
  • Patients with refractory arterial hypertension.
  • Patients who do not attend ≥ 2 nutritional interventions.
  • Patients who present serious complications during the intervention (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344549


Contacts
Contact: Ari Cisneros, bachelor 011 52 3335762299 aricisneroshernandez@gmail.com
Contact: Fabiola Martin del Campo, Master 011 52 3310711190 fabi_mc@hotmail.com

Locations
Mexico
Hospital Civil Nuevo Juan I Menchaca Recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Jorge Andrade Sierra    521 3311747258    jorg_andrade@hotmail.com   
Sponsors and Collaborators
Hospital Civil Juan I. Menchaca
Investigators
Principal Investigator: Ari Cisneros, Bachelor Hospital Civil Juan I. Menchaca

Additional Information:
Publications:

Responsible Party: Andrea Garcia Contreras, Ari Cisneros Hernández, Hospital Civil Juan I. Menchaca
ClinicalTrials.gov Identifier: NCT03344549     History of Changes
Other Study ID Numbers: HCN001
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrea Garcia Contreras, Hospital Civil Juan I. Menchaca:
eHealth
Nutrition Therapy
Telehealth
Diabetic Kidney Disease
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases