Multidisciplinary Care for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes (PreCPro)

NCT ID: NCT06468553

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2027-03-01

Brief Summary

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.

Detailed Description

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.

Conditions

PreDiabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prediabetes Care Program

Intervention composed of an interdisciplinary care team, patient-centered care approach for behavior change for the adoption of healthy eating and physical activity

Group Type: EXPERIMENTAL

Prediabetes Care Program

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PreCPro

Eligibility Criteria

Inclusion Criteria

• Having diagnosis of prediabetes
• Acceptance for participation in the program by signing informed consent sheet

Exclusion Criteria

• Any type of diabetes
• Advanced diseases such as ischemic heart disease, heart failure, KDOQI renal failure ≥1, cerebral vascular disease with functional sequelae or those who have comorbidities that limit their life expectancy such as malignant tumors in advanced stages
• Dependence of illicit drugs
• Conditions that require short-term surgical treatment.
• Pregnancy
• Advanced cognitive deficit or serious psychiatric disorders that hinder treatment adherence
• Use of medications whose use is associated with alterations in blood glucose levels or weight gain or loss, e.g. e.g. metformin, Glucagon-like peptide-1 receptor agonists, orlistat or corticosteroids
• Actively taking any supplements dietary or under naturopathic, homeopathic or alternative therapies
• Have any type of bariatric surgery procedure or weight loss device
• Current participation in another lifestyle, behavior change, or weight loss or gain program or research study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruben Silva-Tinoco, MD

Role: STUDY_DIRECTOR

Clinica Especializada en el Manejo de la Diabetes

Viridiana De la Torre-Saldaña, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Especializada en el Manejo de la Diabetes

Locations

Clinica Especializada en el Manejo de la Diabetes

Mexico City, Iztapalapa, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Ruben Silva-Tinoco, MD

Role: CONTACT

ruben_ost@hotmail.com

50381700 ext. 6690

Viridiana De la Torre-Saldaña, MD

Role: CONTACT

dradelatorreviridiana@gmail.com

50381700 ext. 6699

Facility Contacts

Ruben Silva-Tinoco, MD

Role: primary

ruben_ost@hotmail.com

50381700 ext. 6690

Viridiana De la Torre-Saldaña, MD

Role: backup

dradelatorreviridiana@gmail.com

50381700 ext. 6699

References

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

Reference Type: BACKGROUND

PMID: 11832527 (View on PubMed)

Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th edition. Brussels: International Diabetes Federation; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK581934/

Reference Type: BACKGROUND

PMID: 35914061 (View on PubMed)

Basto-Abreu A, Lopez-Olmedo N, Rojas-Martinez R, Aguilar-Salinas CA, Moreno-Banda GL, Carnalla M, Rivera JA, Romero-Martinez M, Barquera S, Barrientos-Gutierrez T. Prevalencia de prediabetes y diabetes en Mexico: Ensanut 2022. Salud Publica Mex. 2023 Jun 13;65:s163-s168. doi: 10.21149/14832. Spanish.

Reference Type: BACKGROUND

PMID: 38060942 (View on PubMed)

Other Identifiers

101 - 010 - 022 - 23

Identifier Type: -

Identifier Source: org_study_id