Clinical trial NCT03234946: Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus
Official title: Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Diabetes
Family
Impaired fasting-glucose
Carbohydrate intolerance
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Mexican National Institute of Public Health
First posted: 2017-08-01
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Relatives of CAIPaDi patients that present on their initial evaluation either overweight, obesity, hypertension, glucose intolerance and/or secondary dyslipidemia will be invited to participate.

Those who accept will require to attend the center twice. On the first visit, an anthropometric evaluation and laboratory studies will be performed; an oral glucose tolerance (OGTT) test will be carried out if the glucose value is over 100 mg/dl. If the OGTT results are abnormal, the individual will be included in the study sample.

Those who have an abnormal OGTT and are included in the study sample will be randomized into two groups.

The change of the main variables (weight, waist circumference, serum glucose, glycated hemoglobin, blood pressure, triglycerides and non-HDL cholesterol) will be assessed 3 months later, along with the effect on patients with diabetes parameters.
Primary purpose: PREVENTION

Brief summary: Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the whole family. Hence, during the last decade, studies have focused mainly in the role of the members of the family and their influence in life quality or clinical outcomes of patients with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes mellitus may restrict the expectations of success in achieving the necessary modifications in lifestyle.

Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the Patients with Diabetes) program interventions on various health indicators relatives of patients with type 2 diabetes mellitus.

Detailed description: Diabetes mellitus is one of the most challenging health issues of our time, the percentage of adults with this disease tripled in Mexico between 1993 and 2012; In 1993 the prevalence was 6.7% (cases previously diagnosed 4.6% and diagnosed during the survey 2.1%), whereas in 2012, the prevalence was 14.4% (7.3% previously diagnosed and 7.1% diagnosed during the survey) Identifying individuals at risk for developing diabetes and implementing prevention strategies is the optimal solution. Carbohydrate intolerance and impaired fasting glucose raise the risk of developing diabetes up to 20 times compared to those with normal levels of HbA1C and a progression rate to diabetes of 10% per year in the absence of any intervention.

Randomized studies have shown that progression from impaired fasting glucose and glucose intolerance to type 2 diabetes mellitus and its complications can be prevented by interventions focused on changes in lifestyle. This contributed to the implementation of new guidelines for the management of prediabetes, emphasizing the importance of timely interventions in this condition, which may be the most cost-effective alternative to avoid complications.

One of the most important studies in primary diabetes prevention, the Diabetes Prevention Program (DPP), provided scientific evidence on the prevention and delay in the onset of diabetes in high-risk individuals, with a 58% risk reduction through lifestyle modifications, such as reduced fat and calorie intake, increased physical activity up to at least 150 minutes per week and loss of 5-7% of body weight.

Another multicenter, randomized trial, the Finnish Diabetes Prevention Study (DPS), showed that type 2 diabetes is preventable with lifestyle multidisciplinary interventions, with a 58% risk reduction similar to that of the DPP study in the group who received intensive treatment, compared to the control group, even significant changes were observed in metabolic parameters one and three years afterwards.

In addition, a randomized, multicenter study in the city of Da Qing, China, with a population of 110,660 participants, demonstrated that diet and / or exercise lead to a significant decrease in the incidence of diabetes over a 6-year period in patients with carbohydrate intolerance, with an incidence of 67.7% in the control group, 43.8% in the group undergoing dietary changes and 46% in the diet and exercise group.

Family history of diabetes is an independent risk factor for having the disease and provides information for the screening of individuals at risk and even represents an even more sensitive indicator than the presence of obesity.

Diabetes is a chronic disease that involves changes in the patient's lifestyle that can affect the whole family. During the last decade, studies have focused mainly on the role of family members and their influence on the quality of life or clinical course of patients with diabetes. Therefore, providing education only to the individual diagnosed with type 2 diabetes could restrict the chances of success in achieving the necessary changes in lifestyle.

Some studies have shown that the familial nature of type 2 diabetes is manifested by the presence of insulin resistance in first-degree relatives without diabetes, while others have revealed B-cell dysfunction, it seems that both insulin resistance and a diminished B-cell compensation are the family metabolic phenotype of type 2 diabetes mellitus. This highlights the importance of providing diabetes education not only to the patient, but also to their relatives, especially those who already have additional risk factors or prediabetes.

In cross-sectional studies of diabetes, social support has been associated with a better glycemic control in type 2 diabetes and is positively related to overall health status and lifestyle changes. Additionally, the health status of family members of patients attending the sessions has been demonstrated, and social and family support in general is positively linked to health status and transcendental changes in lifestyle.

These findings are justified by the results of the second multinational study, Diabetes Attitudes, Wishes and Needs (DAWN2TM), in which the disease was studied from the perspective of family members, patients and health professionals. Family members who deemed a greater responsibility for the management of diabetes had a lower quality of life and higher levels of disease impact and perceived burden, while less responsibility for the management of diabetes perceived by the patient's family members and an effective collaboration among them correlates with improved psychological well-being and quality of life for family members.

Diabetes is associated with a sense of social disadvantage and stress not only in patients with diabetes but also in the members of their family, so there is a need to foster a larger network of family support through educational programs and to involve them in the treatment of the illness.

To date there are no studies that accurately analyze the impact of social support on maintaining lifestyle changes in a supportive group setting.

The study Families United analyzed the effect of social support in the prevention of diabetes, which has proved to be important for its management and even for other diseases such as obesity, it has been used to convey information regarding prevention of diabetes to minority and high-risk groups in communities.

The social context in which the patient carries out self-care activities determines its success, so that obstructive behaviors such as sabotage or underestimating the patient's effort or hampering their self-care are associated with a greater HbA1C and a reduction of motivation and adherence to treatment, diet plan and exercise.

Despite the high prevalence of obstructive behaviors among relatives of patients with diabetes, few interventions focus on the negative aspects of family interactions.

Family support behaviors or sabotage in diabetes have been independently associated with adherence to self-care behavior and glycemic control among adults with diabetes and low sociocultural level. DAWN-II found that more than one-third of family members wish to be more involved in managing the patient's disease.

A study was conducted in 2013 based on socio-cognitive theory, which focuses on the influence of the social environment (family members) on changes in health habits to overcome barriers to self-management of diabetes and improve self-efficacy. With a population of 36 patients and 37 relatives, with a duration of 14.6 months. The intervention consisted of 2 family sessions and 8 weekly group educational sessions for participants and their families. It was possible to demonstrate positive effects on systolic blood pressure, knowledge of diabetes, self-efficacy, self-management of general and specific diet, glucose monitoring, foot care, fruit and vegetable consumption and physical and mental components associated with quality of life in the participants. There was also a significant improvement in BMI and knowledge of diabetes in family members, suggesting that a culturally-tailored diabetes education program provides a significant benefit to both Hispanic patients with diabetes and their families. In addition, it has been observed that total family involvement in diabetes education helps to increase knowledge, attitude and practice scores in patients with type 2 diabetes mellitus and to improve their quality of life, with significant effects on glycemic control and weight.

For this reason, a collaborative therapeutic partnership between the patient, his family and health care providers is essential, encouraging family members to participate in programs to avoid patient isolation, maintaining family cohesion and promoting health behaviors that reduce the risk and early onset of diabetes in family members.

Eligibility criteria: Inclusion Criteria:

* Being a relative of a patient of CAIPaDi
* Fasting glucose of \<125 mg/dl
* Serum glucose of \<199 mg/dl 2 hours after a glucose load of 75 gr

Exclusion Criteria:

* Diagnosis of diabetes
* Smoking
* Who has any disabling or priority health condition other than prevention of diabetes

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 1 year
measure: Body Mass Index
timeFrame: 1 year
Secondary outcomes:
measure: Serum glucose
timeFrame: 1 year
measure: Non-HDL cholesterol
timeFrame: 1 year
measure: Triglycerides
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: Weight loss
timeFrame: 1 year
measure: Waist circumference
timeFrame: 1 year
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 1 year
measure: Minutes of exercise per day
timeFrame: 1 year
measure: Steps per day
timeFrame: 1 year
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: Instituto Nacional de Salud Pública
state: Morelos
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Grade A Specialized Physician
name: Ana C García Ulloa, MD
role: PRINCIPAL_INVESTIGATOR
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