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

NCT06468553 | Recruiting DMC

• 1 other identifier: 101 - 010 - 022 - 23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

glycemic control; weight loss; Healthy Lifestyle; Prediabetic State; quality of life; Glucose Metabolism Disorders; Behavior and Behavior Mechanisms; Exercise; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

  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

  six months

Secondary Outcomes (13)

• Glycemic control

  twenty four months

• Weight change

  twenty four months

• Lipid control

  twenty four months

• Blood pressure

  twenty four months

• Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire

  twenty four months

Study Arms (1)

Prediabetes Care Program

EXPERIMENTAL

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

Interventions

Prediabetes Care Program 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

Also known as: PreCPro

Prediabetes Care Program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico: lead

Study Sites (1)

Clinica Especializada en el Manejo de la Diabetes

Mexico City, Iztapalapa, 09060, Mexico

RECRUITING

Related Publications (3)

• 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.

  PMID: 11832527 BACKGROUND

• 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/

  PMID: 35914061 BACKGROUND

• 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.

  PMID: 38060942 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Weight Loss; Glucose Metabolism Disorders; Behavior; Motor Activity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruben Silva-Tinoco, MD

  Clinica Especializada en el Manejo de la Diabetes

  STUDY DIRECTOR

• Viridiana De la Torre-Saldaña, MD

  Clinica Especializada en el Manejo de la Diabetes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Silva-Tinoco, MD

CONTACT

50381700; ruben_ost@hotmail.com

Viridiana De la Torre-Saldaña, MD

CONTACT

50381700; dradelatorreviridiana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The impact of the intervention on the change in weight and glycated hemoglobin will be determined, secondarily the change in quality of life will also be measured, using a "before and after" design. Subjects who attend the Specialized Diabetes Management Clinic and meet the selection criteria will be included in this study. Once their admission to the study has been decided, subjects will be able to participate in the recruitment and intervention stage and then in the annual follow-up stage

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

ME (1)