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.
Phase: NA
Conditions: Diet Modification, Diabetic Kidney Disease, Chronic Kidney Diseases
Sponsor: Hospital Civil Juan I. Menchaca

 
 
 
Clinical study protocol 
Effect of the Teleconsultation of Renal Nutrition on Renal 
Function and Glycemic Control in Patients With DKD 
 
Protocol number: NCT03344549 
Date: 30 october 2022 
 
 
 
 
 

INTRODUCTION 
Diabetic kidney disease (DKD) is the leading cause of end-stage renal disease(1). The 
progression of diabetic nephropathy can be delayed by optimal glycemic control. 
Nutritional therapy with sugar control and low protein diets (0.8 g/kg/day) are the most 
recommended (2) however, it is difficult to achieve compliance (3). The dimensions of 
chronic kidney disease show it as a public health problem that requires the creation of new 
interventional and educational programs (4). Telehealth may improve clinical outcomes, 
care coordination, engagement, and satisfaction. 
METHODS 
Primary objective 
 
The main goal of the study, a randomized and controlled study, is to determine a 
difference between the nutritional intervention through teleconsultation and the face-to-face 
consultation in patients with diabetic kidney disease in stage G3a, G3b and G4. 
Study design 
The trial will be a prospective, randomized, open, controlled design that will last 4 months. 
The trial was registered in the clinicaltrials.gov registry (ClinicalTrials.gov identifier: 
NCT03344549). 
Study population 

A total of 53 adult volunteers with a diagnosis of DKD will be recruited for this study. To 
be eligible in the trial, subjects must fulfil all of the inclusion criteria and none of the 
exclusion criteria, as stated below.  
The following inclusion criterio will be adopted: 
(1) Outpatients aged 18–80 years. 
(2) With DKD with eGFR <60 ml / min / 1.73m2 and ≥ 15 ml / min / 1.73m2, (stage 
G3a, G3b and G4 respectively). 
(3) Written informed consent to participate in this study before any study-mandated 
procedure. 
(4) Who have access to the internet and have a computer, tablet or smartphone. 
(5) A willingness and motivation to follow the study protocol.  
The exclusion criteria will be as follows: 
(1) Outpatients who have received prior nutritional treatment for the control of diabetic 
kidney disease. 
(2) The use of food supplements and / or keto analogues. 
(3) Diagnosis of anemia or recent transfusions (in the last 3 months). 
(4) With serious complications (chronic infection, septicemia, cancer, HIV, 
Alzheimer's, uncontrolled heart failure, liver failure, refractory arterial 
hypertension, etc.). 

(5) Patients with serious difficulties in communication or intellectual deficit that 
impedes the ability to understand the intervention. 
Reasons for the participant to be discontinued from the study: 
(1) Withdrawal of informed consent. 
(2) Non-attendance at the study visits (≥ 2 nutritional interventions), 
(3) Exclusion criteria found after enrollment, and 
(4) Any serious adverse event during the intervention period (based on data safety 
monitoring). 
(5) Admission to dialysis 
Figure 1. CONSORT Flow Diagram 
 
 
 
 
 
 
 
 
Assessed for eligibility (n=76) 
Excluded (n= 25) 
   Not meeting inclusion criteria (n=21) 
   Declined to participate (n=4) 
Allocated to intervention (n=26) 
 Received allocated intervention (n=26) 
Allocated to control intervention (n= 27) 
 Received allocated control intervention (n= 
27) 
Allocation 
Follow-Up 
Randomized (n= 53) 
Enrollment 

 
 
 
 
 
 
 
 
 
Sample size calculation 
For the calculation of sample size, the formula was used to compare means of independent 
samples. A size of 27 patients per group was estimated, considering an expected difference 
in the Glycated Hemoglobin percentage of 0.7 reported in a previous study (6). 
Randominzation 
Randomization was performed using the simple method without replacement with sealed 
envelopes. Recruited individuals will be allocated into one of two groups: 
(1) Teleconsultation (n =26) 
(2) Face to face consultation (n =27) 
Analysed (n= 19) 
Lost to follow-up (n= 7) 
 Non-attendance at visits (n=3) 
 Admission to dialysis (n=2) 
 Cancer diagnosis (n=1) 
 Lack of electronic device (n=1) 
Lost to follow-up (n=15) 
 Withdrawal of informed consent (n=2) 
 Non-attendance at the study visits due to 
transportation difficulties (n=13) 
Analysed (n=12) 
Analysis 

DIETARY INTERVENTIONS 
The teleconsultation group received nutritional therapy by video call in real time, with a 
monthly frequency for 4 months. The consultation includes the evaluation or reevaluation, 
diagnostic treatment and educational approach. Failure to attend more than two 
consultations is considered an exclusion criterion. 
The Face to face consultation group, received nutritional therapy through face-to-face 
consultations in the hospital with a monthly frequency for 4 months. The consultation 
includes the evaluation or re-evaluation, diagnosis, treatment and educational approach. 
Failure to attend more than two consultations is considered an exclusion criterion. 
DATA ANALISIS PRINCIPLES  
To determine the difference between the nutritional interventions, the following changes 
from the baseline (I1) to the end of the study (I6) will be determined as primary outcomes: 
(1) Renal function with de the determination of the changes in the estimated 
glomerular filtration rate (eGFR) 
(2) Glycemic control with the determination of the changes in the  Hemoglobin A1c 
(HbA1c) 
To evaluate the adhrence to nutritional interventions were determined as secondary 
outcome: 
(1) Level of compliance, was assessed using a self-reported Likert scale. Being the 
score 10 = good adherence and the score 1 = poor adherence to treatment. 

STUDY PROCEDURES 
The detection of patients is carried out in the nephrology department of the Juan I. 
Menchaca hospital, both in the morning and afternoon sessions. The identification of 
patients is carried out during the consultation with the nephrologist, where the selection 
criteria are evaluated and the patient is invited to participate in the study and to sign the 
agree consent. 
After the patient's acceptance to participate in the study, the initial evaluation is carried out, 
which includes contact, demographic, anthropometric and dietary data; and the patient is 
trained to fill the dietary record at home. Anthropometric data are evaluated by 
standardized nutritionist trained with the correct technique. Venous blood was collected by 
qualified nurses. The biochemical indicators are requested by the nephrologist at the time of 
the consultation and the results of these are obtained from the institution's own data system. 
After the initial evaluation, the probabilistic group assignment is carried out with the simple 
method without replacement, which is carried out using a sealed envelope. After the 
appointment of the group, the patient is scheduled for his first nutrition consultation (both 
arms). 
In the teleconsultation group, two days before the first nutrition consultation, the patient is 
advised by telephone - or the family member in charge - about the use of the free 
technological tool to be used during the video conference. 
In the patients of the intervention 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); and the patients of the control group are offered the 
nutritional intervention through face-to-face consultations carried out by the nutritionist of 
the nutrition service of the institution. All patients will be confirmed by phone the date and 
time of their next nutrition consultation, both the control group and the intervention group 
(Table.1) 
Table 1. Timeline of the study 
Time (weeks) 
from start of 
dietary 
intervention 
Pre-
baseline 
Study period 
Close-
out 
Baseline 
 
(I0) 
Week -1 
(I1) 
Week 0 
(I2) 
Week 4 
(I3) 
Week 8 
(I4) 
Week 
12 
(I5) 
Week 
16 
(I6) 
Week 
18 
Screening and 
sign the agree 
consent. 
x 
 
 
 
 
 
 
Randomization 
x 
 
 
 
 
 
 
Socio-
demographic data 
x 
 
 
 
 
 
 
Blood serum 
measurements 
x 
 
 
 
 
 
x 

Dietary habits 
x 
 
 
 
 
 
x 
Anthropometric 
measures 
x 
 
 
 
 
 
x 
Nutritional 
intervention 
 
x 
x 
x 
x 
x 
 
Level of 
compliance 
 
 
x 
x 
x 
x 
 
Data colletion  
The following clinical/dietary information was obtained: 
• Socio-demographic data (a questionnaire). 
• Dietary habits:  a 3-day food record. 
• Vital signs: blood pressure. 
• Anthropometric measures: weight, height, body mass index (BMI). 
• Gastrointestinal symptoms: frequency and duration. 
In the blood serum, we evaluated markers of glucose, and hemoglobin A1c; serum 
creatinine, urea, albúmin and blood biometry. 
STATISTICAL ANALISIS PLAN 
Categorical variables are presented as numbers and percentages, and comparisons between 
groups were performed with the chi-square or Fisher exact test as appropriate. According to 

the Shapiro‒Wilk test for data distribution, continuous variables are summarized as the 
means ± standard deviations (SD) if normally distributed or medians and interquartile 
ranges (25–75th) if non-normally distributed and were compared using Student’s t-test or 
the Mann‒Whitney U test, respectively. For variables measured at multiple time points, 
repeated measures analysis of variance tests were used for the comparisons between groups 
For the analysis of the interaction or intervening variables, a stratified statistical analysis 
will be carried out, using contingency tables and the Mantel-Haenszel method. All tests 
were two-tailed, and a p value less than 0.05 were considered significant. Statistical 
analysis and graphics were performed with IBM® SPSS® Stadistics Ver. 22). 
ETHICS APPROVAL AND CONSENT TO PARTICIPATE 
The trial was conducted in accordance with the principles of the Declaration of Helsinki 
and the International Conference on Harmonization Guidelines for Good Clinical Practice. 
All patients gave their written informed consent before any study-related procedure. The 
study was approved by the local ethics committee (14 CEI 14 039 048), was prospectively 
registered in clinicaltrials.gov (NCT03344549). No funding was received to conduct this 
study. The clinical trial was carried out under the CONSORT guidelines. 
Informed consent was obtained from all subjects. All methods were carried out in 
accordance with relevant guidelines and regulations. All experimental protocols were 
approved by the Institutional Review Board “Comité de ética en Investigación del OPD 
Hospital Civil de Guadalajara Dr. Juan I. Menchaca” 
 

CONSENT FOR PUBLICATION 
INFORMED CONSENT FORM FOR MINIMAL RISK STUDY 
Date: ____________________, Guadalajara Jalisco, México. 
I hereby agree to participate in the research project entitled: 
“Effect of the Teleconsultation of Renal Nutrition on Renal Function and Glycemic Control 
in Patients With DKD” 
I understand that the purpose of this study is to identify the effect of remote nutrition 
intervention on glycemic control and kidney function in people with diabetic chronic 
kidney disease. Adequate nutrition plays an important role in the treatment of diabetes and 
chronic kidney disease, it has been shown that it is essential to slow down the deterioration 
of kidney function. 
It has been explained to me that my participation will consist of: 
1. 
I will answer a questionnaire about personal, socio-demographic data and history of 
illnesses. 
2. 
They will take measurements of my nutritional status including weight, height, arm 
circumference and triceps skinfold. 
3. 
They will request blood tests from me at the beginning, at the middle and at the end 
of the study. 
4. 
I will attend 5 monthly nutrition consultations in the hospital or at home. 

5. 
I will adhere to the indicated medical and nutritional recommendations. 
I declare that I have been fully informed about the possible risks, inconveniences, perjury 
and benefits derived from participation in the study. Which are the following: 
Risks: It is important that you provide true and complete information about your medical 
history and health status. During this study you will not receive any extra medication than 
the usual ones for the treatment of your disease, we will closely monitor you, and we will 
make sure that you receive the appropriate treatment in case you develop any 
complications. The nutritional evaluation, as well as the obtaining of blood samples, do not 
imply risks to your health. 
Benefits: the main benefit is to identify whether remote nutritional intervention maintains 
renal function and glycemic control in the population with chronic kidney disease. This will 
give the opportunity to implement this modality in other people with kidney disease. You 
will be closely monitored by a team of specialist doctors and nutritionists to avoid any 
complications. All the information obtained from this study will be handled with discretion, 
maintaining the confidentiality of the data. 
The responsible investigator has agreed to give me timely information about any 
appropriate alternative procedure that could be advantageous for my treatment, as well as to 
answer any questions and clarify any doubts that may arise about the procedures that will 
be carried out, the risks, benefits or any other matter related to the research or my 
treatment. 

I understand that I have the right to withdraw from the study at any time I deem necessary, 
without affecting future medical care. 
The responsible investigator has assured me that I will not be identified in the presentations 
or publications that derive from this study and that the data related to my privacy will be 
handled confidentially. He has also agreed to provide me with updated information that is 
obtained during the study, even if he could change his mind about my remaining in the 
study. 
___________________________________________ 
Patient name and signature 
________________________________________ 
Name and signature of the responsible investigator 
________________________________          
Name and signature of the first witness 
  _______________________________ 
 Name and signature of the second witness 
  _______________________________ 
The telephone number to which you can contact in case of questions related to the study is: 
044 33 35 76 22 99. 

REFERENCES 
1. García-García G, Márquez-Magaña I, Renoirte-López K, et al. Screening for kidney 
disease on World Kidney Day in Jalisco, J Nephrol. 2010; 23(02): 224 – 230.  
2. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 
2017; 40 (1): S1 – S135.  
3. Bellizzi V. Low-Protein Diet or Nutritional Therapy in Chronic Kidney Disease?. Blood 
Purif. 2013; 36 :41–46.  
4. Martínez-Ramírez HR, Cortes-Sanabria L, Rojas-Campos E, et al. Multidisciplinary 
strategies in the management of early chronic kidney disease. Archives of Medical 
Research. 2013; 44: 611 - 615.  
5. Klug C, Bonin K, Bultemeier N, et al. Integrating Telehealth Technology into a Clinical 
Pharmacy Telephonic Diabetes Management Program. J Diabetes Sci Technol.2011; 5(5): 
1238 – 1245. 
6. Meloni C, Morosetti M, Suraci C, et al. Severe dietary protein restriction in overt 
diabetic nephropathy: ¿benefits or risks?. J Ren Nutr. 2002; 12(2): 96 – 101.