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Clinical Trials/NCT03344549
NCT03344549CompletedNot Applicable

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.

Hospital Civil Juan I. Menchaca2 sites in 1 country53 target enrollmentStarted: December 28, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
53
Locations
2
Primary Endpoint
Glycemic Control

Study Overview

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).

Detailed Description

Chronic kidney disease (CKD) is the result of various chronic-degenerative diseases, including diabetes mellitus. In Mexico, it is considered a catastrophic disease due to the increasing number of cases, high investment costs and human resources, limited infrastructure, late detection of the disease, and high rates of morbidity and mortality in substitution programs.

So far, there is no record of patients with CKD in Mexico, so the precise number of patients in any of their stages is unknown. International databases, estimate an incidence of 421 patients with terminal CKD treated per million of population per year in our country (represented by the state of Jalisco), and a prevalence of 1,568 cases per million of population; figures that are considered the highest in the world.

Currently our country lives an extraordinarily complex scenario, has shown the highest rate of incidence of terminal kidney disease in recent years, which may be related, at least in part, to the increase in the prevalence of risk factors and the incongruence between needs of patients and the health care system, largely designed for the management of acute diseases. The CKD is among the first 10 causes of general mortality in Mexico, with a survival calculated in average months, from the entrance to a substitution therapy, of 30.6 months. The medical expense provided by the Mexican Institute of Social Security (an public agency that provides coverage to 66% of Mexicans with social security), for the treatment of terminal CKD in 2007, was estimated at $ 4 billion pesos, equivalent 60% of the total medical expense; and it is estimated that, due to the high incidence rates, in 2043 the investment costs will reach 20 billion pesos, figures that can not be paid.

The dimensions of chronic kidney disease show it as a public health problem that requires the creation of new intervention and education programs focused on the prevention of kidney disease and its causes. Currently, doctors have serious difficulties in providing optimal management. It is common for patients during the early stages of CKD not to comply with recommendations for effective control. They usually present negative life habits, difficult to change only with medical intervention. Many of the risk factors for both the onset and progression of CKD are related to unhealthy eating habits. It is widely known that, optimizing the quality of diet and lifestyles, in individuals with CKD at early stages have substantial benefits in terms of preventing the incidence and progression of the disease, as well as in the mortality of this population. Interventions based on multidisciplinary models, developed in populations at risk and in early stages of kidney disease have proven useful for delaying progression and postponing patients' admission to substitution therapy.

As the CKD progresses, the risk of presenting complications such as malnutrition, hyperphosphatemia and hyperkalemia increases significantly, which increases the risk of morbidity and mortality, especially in more advanced stages of the disease. Nutrition interventions to control and modify these risk behaviors become key points for the management of patients with CKD.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.).

Outcomes

Primary Outcomes

Glycemic Control

Time Frame: Baseline and at 4 month

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.

Renal Function

Time Frame: Baseline and at 4 month

Determination 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.

Secondary Outcomes

  • Number of Participants With Adherence to Treatment(Baseline and at 5 month)

Investigators

Sponsor
Hospital Civil Juan I. Menchaca
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Garcia Contreras

Ari Cisneros Hernández

Hospital Civil Juan I. Menchaca

Study Sites (2)

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