PreDiabetesPreCProNCT06468553
Multidisciplinary Care for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes (PreCPro)
A study testing Prediabetes Care Program in people with PreDiabetes, run by Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Prediabetes Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having diagnosis of prediabetes
- Acceptance for participation in the program by signing informed consent sheet
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Clinica Especializada en el Manejo de la Diabetes
Mexico City, Iztapalapa, 09060
Ruben Silva-Tinoco, MD, 50381700 ext. 6690, ruben_ost@hotmail.com
Viridiana De la Torre-Saldaña, MD, 50381700 ext. 6699, dradelatorreviridiana@gmail.com
About this study
Official title: Impact of a Multidisciplinary Care Program for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes: Prediabetes Care Program of Mexico City
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.
Read the 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
- Being tested
- Prediabetes Care Program
- Keywords
- glycemic control, weight loss, Healthy Lifestyle, Prediabetic State, quality of life, Glucose Metabolism Disorders, Behavior and Behavior Mechanisms, Exercise, Diabetes Mellitus, Type 2
- Medical subject headings
- Prediabetic State, Weight Loss, Glucose Metabolism Disorders, Behavior, Motor Activity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediabetes Care ProgramBehavioural
Also called PreCPro
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Prediabetes Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: six months
Secondary outcomes (13)
Glycemic control
HbA1c (percentage): HbA1c will be compared from the last visit (twelve months) and the 24-month visit
Measured: twenty four months
Weight change
Weight change (kg) will be compared from the last visit (twelve months) and the 24-month visit
Measured: 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
Measured: 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
Measured: 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
Measured: twenty four months
Glycemic control
HbA1c (percentage): HbA1c will be compared from the visit on the six months with the last visit (12 month)
Measured: twelve months
Weight change
Weight Change in kilograms will be compared from the visit on the six months with the last visit (12 month)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: six months
Blood pressure
Systolic and diastolic blood pressure (mmHg) will be compared from the first visit with the visit to six months later
Measured: 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
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ruben Silva-Tinoco, MD, Study director, Clinica Especializada en el Manejo de la DiabetesViridiana De la Torre-Saldaña, MD, Principal investigator, Clinica Especializada en el Manejo de la Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468553
- Sponsor's protocol ID
- 101 - 010 - 022 - 23
- Acronym
- PreCPro
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 11832527Magliano 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/
PubMed 35914061Basto-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.
PubMed 38060942
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multidisciplinary Care Program for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes: Prediabetes Care Program of Mexico City
- ClinicalTrials.gov ID
- NCT06468553
- Acronym / sponsor ID
- PreCPro / 101 - 010 - 022 - 23
- Conditions
- PreDiabetes
- Keywords
- glycemic control, weight loss, Healthy Lifestyle, Prediabetic State, quality of life, Glucose Metabolism Disorders, Behavior and Behavior Mechanisms, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Clinica Especializada en el Manejo de la Diabetes en la Ciudad de MexicoResearch network
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Prediabetes Care Program | Experimental | Behavioral: Prediabetes Care ProgramIntervention composed of an interdisciplinary care team, patient-centered care approach for behavior change for the adoption of healthy eating and physical activity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having diagnosis of prediabetes
- Acceptance for participation in the program by signing informed consent sheet
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prediabetes Care ProgramAlso: PreCProPatients 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 | Behavioural | Prediabetes Care Program |
Primary outcome
Glycemic control after the initial stage of the program
Time frame: six months
HbA1c (percentage): HbA1c will be compared from the first visit with the visit six months later
Change in weight after the initial stage of the program
Time frame: six months
Weight in kilograms. Weight will be compared from the first visit with the visit to six months later
13 secondary outcomes
Glycemic control
Time frame: twenty four months
Weight change
Time frame: twenty four months
Lipid control
Time frame: twenty four months
Blood pressure
Time frame: twenty four months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Time frame: twenty four months
Glycemic control
Time frame: twelve months
Weight change
Time frame: twelve months
Lipid control
Time frame: twelve months
Blood pressure
Time frame: twelve months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Time frame: twelve months
Lipid control
Time frame: six months
Blood pressure
Time frame: six months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 11832527Knowler 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.
- Background: PubMed 35914061Magliano 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/
- Background: PubMed 38060942Basto-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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruben Silva-Tinoco, MD study director
Clinica Especializada en el Manejo de la Diabetes
Viridiana De la Torre-Saldaña, MD principal investigator
Clinica Especializada en el Manejo de la Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prediabetes Care Program in people with PreDiabetes, run by Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruben Silva-Tinoco, MD (50381700 ext. 6690, ruben_ost@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control after the initial stage of the program (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468553, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.