Trial Outcomes & Findings for Effect of the Teleconsultation of Renal Nutrition on Renal Function and Glycemic Control in Patients With DKD (NCT NCT03344549)
NCT ID: NCT03344549
Last Updated: 2024-09-23
Results Overview
Determination of glycated hemoglobin (HbA1c) levels at the beginning and end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Baseline and at 4 month
Results posted on
2024-09-23
Participant Flow
Participant milestones
| Measure |
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).
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
19
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
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).
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.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Dialysis
|
2
|
0
|
|
Overall Study
Cancer
|
1
|
0
|
|
Overall Study
Lack of electronic device
|
1
|
0
|
|
Overall Study
Transportation difficulty
|
0
|
13
|
Baseline Characteristics
Only participants who completed the intervention
Baseline characteristics by cohort
| Measure |
Teleconsultation
n=26 Participants
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).
Renal nutrition teleconsultation: Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
|
Face-to-face Consultation
n=27 Participants
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.
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.12 years
STANDARD_DEVIATION 12.05 • n=26 Participants
|
64.15 years
STANDARD_DEVIATION 11.71 • n=27 Participants
|
63.13 years
STANDARD_DEVIATION 11.8 • n=53 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=26 Participants
|
12 Participants
n=27 Participants
|
30 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=26 Participants
|
15 Participants
n=27 Participants
|
23 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=26 Participants
|
27 Participants
n=27 Participants
|
53 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=53 Participants
|
|
Duration of diabetes
|
16.08 years
STANDARD_DEVIATION 8.52 • n=26 Participants
|
21.3 years
STANDARD_DEVIATION 9.57 • n=27 Participants
|
18.5 years
STANDARD_DEVIATION 9.3 • n=53 Participants
|
|
Arterial hypertension
|
26 Participants
n=26 Participants
|
24 Participants
n=27 Participants
|
50 Participants
n=53 Participants
|
|
Systolic blood pressure
|
136.68 mm Hg
STANDARD_DEVIATION 25.07 • n=26 Participants
|
140.86 mm Hg
STANDARD_DEVIATION 26.29 • n=27 Participants
|
138.77 mm Hg
STANDARD_DEVIATION 25.68 • n=53 Participants
|
|
Level of education
Incompleted elementary school
|
14 Participants
n=26 Participants
|
10 Participants
n=27 Participants
|
24 Participants
n=53 Participants
|
|
Level of education
Completed elementary school
|
4 Participants
n=26 Participants
|
7 Participants
n=27 Participants
|
11 Participants
n=53 Participants
|
|
Level of education
Incompleted high school
|
6 Participants
n=26 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=53 Participants
|
|
Level of education
High school or more
|
2 Participants
n=26 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=53 Participants
|
|
Access to smartphone
|
26 Participants
n=26 Participants
|
26 Participants
n=27 Participants
|
52 Participants
n=53 Participants
|
|
Access to computer
|
8 Participants
n=26 Participants
|
7 Participants
n=27 Participants
|
15 Participants
n=53 Participants
|
|
Hemoglobin A1c
|
8.2 percentage of Hemoglobin A1c
STANDARD_DEVIATION 2.23 • n=19 Participants • Only participants who completed the intervention
|
7.37 percentage of Hemoglobin A1c
STANDARD_DEVIATION 1.41 • n=12 Participants • Only participants who completed the intervention
|
7.86 percentage of Hemoglobin A1c
STANDARD_DEVIATION 1.82 • n=31 Participants • Only participants who completed the intervention
|
|
Glycemic control
|
14 Participants
n=26 Participants
|
20 Participants
n=27 Participants
|
34 Participants
n=53 Participants
|
|
Glomerular filtration rate
|
32.66 ml/min/1.73 m^2
STANDARD_DEVIATION 12.28 • n=19 Participants • Participants who completed the intervention
|
28.28 ml/min/1.73 m^2
STANDARD_DEVIATION 10.56 • n=12 Participants • Participants who completed the intervention
|
30.97 ml/min/1.73 m^2
STANDARD_DEVIATION 11.42 • n=31 Participants • Participants who completed the intervention
|
PRIMARY outcome
Timeframe: Baseline and at 4 monthDetermination of glycated hemoglobin (HbA1c) levels at the beginning and end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.
Outcome measures
| Measure |
Teleconsultation
n=19 Participants
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).
Renal nutrition teleconsultation: Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
|
Face-to-face Consultation
n=12 Participants
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.
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.
|
|---|---|---|
|
Glycemic Control
|
7.4 percentage of HbA1c
Standard Deviation 1.83
|
7.35 percentage of HbA1c
Standard Deviation 2.25
|
PRIMARY outcome
Timeframe: Baseline and at 4 monthDetermination of the estimated glomerular filtration rate (eGFR), at the end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.
Outcome measures
| Measure |
Teleconsultation
n=19 Participants
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).
Renal nutrition teleconsultation: Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
|
Face-to-face Consultation
n=12 Participants
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.
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.
|
|---|---|---|
|
Renal Function
|
34.45 ml/min/1.73 m^2
Standard Deviation 14.7
|
36.19 ml/min/1.73 m^2
Standard Deviation 27.61
|
SECONDARY outcome
Timeframe: Baseline and at 5 monthTo know the adherence to the level of compliance was assessed using a self-reported Likert scale in both study groups. Being the score 10 = good adherence and the score 1 = poor adherence to treatment.
Outcome measures
| Measure |
Teleconsultation
n=19 Participants
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).
Renal nutrition teleconsultation: Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
|
Face-to-face Consultation
n=12 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Adherence to Treatment
5 to 6 Likert scale
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adherence to Treatment
7 to 8 Likert scale
|
15 Participants
|
7 Participants
|
|
Number of Participants With Adherence to Treatment
9 to 10 Likert scale
|
4 Participants
|
3 Participants
|
Adverse Events
Teleconsultation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Face-to-face Consultation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teleconsultation
n=19 participants at risk
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).
Renal nutrition teleconsultation: Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
|
Face-to-face Consultation
n=12 participants at risk
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.
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.
|
|---|---|---|
|
General disorders
Cancer
|
5.3%
1/19 • Number of events 1 • 4 months
|
0.00%
0/12 • 4 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place