An interventional study of Prediabetes Care Program in PreDiabetes, sponsored by Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico · Not applicable, Interventional, and Prevention
Prediabetes is part of the natural history of type 2 diabetes mellitus, which is one of the main causes of morbidity and mortality in Mexico. It is known that overweight and obesity are the main risk factors for producing insulin resistance and this in turn leads to prediabetes-diabetes mellitus 2, acting alone or together, excess adipose tissue, mainly visceral, and Prediabetes increase cardiovascular risk before hyperglycemia occurs in the diagnostic criteria for diabetes. Effective strategies have been developed focused on changing lifestyle habits (changes in dietary patterns and increased physical activity) to promote weight loss in populations with and without glucose alterations present, but with limitations in the scope for the size of the affected population. There is a small number of studies developed for this purpose, focused on a multidisciplinary intervention in low- and middle-income countries. The prediabetes care program (PreCPro) is a care initiative developed by the primary care public health services of the Government of Mexico City (CDMX) to promote weight reduction and reduction of hyperglycemia through a intervention composed of an interdisciplinary care team, centered on the patient with a focus on promoting change in people's behavior to adopt healthy eating and physical activity habits. The target population of the prediabetes care program (PreCPro) is made up of patients with prediabetes, without advanced diseases, who receive regular care in public primary care services in Mexico City.
Prediabetes is part of a continuum of progressive dysglycemia that is identified with the presence of hyperglycemia resulting from the destruction or dysfunction of β cells that progresses until plasma glucose concentrations are in the range of diabetes mellitus, by which time the condition has already been detected. presence of organ damage that can no longer be fully reversed and subsequently results in increased disability, morbidity and mortality for families and the high cost of treatment for national healthcare systems. The treatment established for the prevention of diabetes mellitus 2 from stages identifiable through the diagnosis of prediabetes focuses on promoting behavioral changes for the adoption of a healthy diet and increased physical activity with the aim of producing weight reduction with consequent remission of the hyperglycemic state. Although effective behavioral programs have been created for this purpose, the best known being the Diabetes Prevention Program (DPP) in the United States and which is part of its national care strategy, similar care has been carried out in low- and middle-income countries with limited scope because it only focuses on small research studies. The barriers to the implementation of this type of care programs are usually lack of financial resources on the part of health institutions, difficulty in adapting established programs to the specific sociocultural characteristics of each population, lack of access to these programs either due to lack of of time or difficulties in attending due to distance on the part of the participants, among others. Weight loss through changes in dietary patterns and increased physical activity has been shown to prevent or delay the progression of prediabetes to diabetes mellitus 2. The PreCPro program is a care initiative developed by the public health services of primary care of the Government of Mexico City based on the pillars (diet and physical activity) recommended by national and international diabetes mellitus prevention guidelines. The target population of the PreCPro program is made up of patients with prediabetes without advanced diseases, who receive regular care in public primary care services in Mexico City.
1,021 studies on the registry are indexed under Prediabetic State; 242 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 861 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Intervention composed of an interdisciplinary care team, patient-centered care approach for behavior change for the adoption of healthy eating and physical activity
Behavioral: Prediabetes Care Program
Patients are cared for by the medical, nutritionist and psychology team, in a total of 14 individual and group visits, during 12 months of care. The intervention has an initial stage lasting 6 months in which 12 visits will be scheduled and a transition stage lasting 6 more months in which 2 more visits will be scheduled. Patients will be evaluated at 6 months, 12 months and 24 months
Also known as: PreCPro
Glycemic control after the initial stage of the program
HbA1c (percentage): HbA1c will be compared from the first visit with the visit six months later
Time frame: six months
Change in weight after the initial stage of the program
Weight in kilograms. Weight will be compared from the first visit with the visit to six months later
Time frame: six months
Glycemic control
HbA1c (percentage): HbA1c will be compared from the last visit (twelve months) and the 24-month visit
Time frame: twenty four months
Weight change
Weight change (kg) will be compared from the last visit (twelve months) and the 24-month visit
Time frame: twenty four months
Lipid control
Total Cholesterol, HDL-Cholesterol, Non-HDL Cholesterol and triglycerides in mg/dL will be compared from the last visit (twelve months) and the 24-month visit
Time frame: twenty four months
Blood pressure
Systolic and diastolic blood pressure (mmHg) will be compared from the last visit (twelve months) and the 24-month visit
Time frame: twenty four months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the last visit (twelve months) and the 24-month visit
Time frame: twenty four months
Glycemic control
HbA1c (percentage): HbA1c will be compared from the visit on the six months with the last visit (12 month)
Time frame: twelve months
Weight change
Weight Change in kilograms will be compared from the visit on the six months with the last visit (12 month)
Time frame: twelve months
Lipid control
Total Cholesterol, HDL-Cholesterol, Non-HDL Cholesterol and triglycerides in mg/dL will be compared from the visit on the six months with the last visit (12 month)
Time frame: twelve months
Blood pressure
Systolic and diastolic blood pressure (mmHg) will be compared from the visit on the six months with the last visit (12 month)
Time frame: twelve months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the visit on the six months with the last visit (12 month)
Time frame: twelve months
Lipid control
Total Cholesterol, HDL-Cholesterol, Non-HDL Cholesterol and triglycerides in mg/dL will be compared from the first visit with the visit to six months late
Time frame: six months
Blood pressure
Systolic and diastolic blood pressure (mmHg) will be compared from the first visit with the visit to six months later
Time frame: six months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the first visit with the visit to six months later
Time frame: six months
Plan to share: Undecided — The availability to share any data from individual participants must be requested primarily to the institutional Research and Ethics Committee by the study investigators.
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Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico