Diabetes Mellitus, Type 2PRuDENTENCT03194009
PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment
A study testing Metformin and Lifestyle intervention in people with Diabetes Mellitus, Type 2 and Prediabetic State, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Prediabetic State
- What is being tested?
- Metformin and Lifestyle intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,060 participants
- Where
- 1 siteMexico
- Study dates
- 10 Aug 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having received primary care in the chosen health center (ideally two or more visits to that clinic in the prior year).
- Subscribers to "Seguro Popular" ( Mexican national health insurance)
- Body mass index >=30 kg / m2
- Results of fasting serum glucose with values for pre-diabetes diagnosis (glucose between 100 and 125 mg / dl)
- Optional:
- Family history of DMT2 (1st grade relative).
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- Previous diagnosis of hypertension or dyslipidaemia.
- Have received antihypertensive medication and / or for cholesterol / lipids.
- History of gestational diabetes mellitus.
Who cannot join
- Renal insufficiency (Glomerular Filtration Rate (GFR) <30 ml/min).
- Known hepatic impairment or altered liver enzymes (aspartate aminotransferase (AST) AST or alanine aminotransferase (ALT) three times above normal values)
- Active alcoholism or drug addiction
- Allergies or previous known intolerance to exercise or metformin.
- Current pregnancy.
- Plans to leave the area in the next three years.
- Previous diagnosis of type 2 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centros de Salud. Secretaría de Salud Ciudad de México
Mexico City, 06820
Alberto Gallardo, MD, +52 (55) 50381700 ext. 1597, albgallardo@yahoo.com.mx
Carmen Vanegas, MD, +52(55) 50381700 ext. 1067, carmenvanegas_5@hotmail.com
About this study
Official title: Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.
The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.
Read the detailed description
Diabetes in Mexico is considered a national emergency given its high prevalence, incidence, mortality and costs. Mexico has one of the highest prevalence of diabetes; in only 6 years (2000 to 2006) this prevalence increased from 7.5% to 14.4%. In 2015, 151 deaths per 100,000 inhabitants occurred in Mexico due to diabetes complications.
Metformin is a hypoglycemia drug and it´s the first line medication for the treatment of type 2 diabetes.There is currently a significant amount of evidence that metformin administration reduces the progression from pre-diabetes to diabetes and, despite its monotherapy being less effective than lifestyle changes, the good biosafety profile and low cost have made it the drug of choice in a joint treatment.
The PRuDENTE study proposes to perform this intervention in a real environment in the clinics of the first level of care of the Ministry of Health of the Government of Mexico City, in order to provide evidence about the cost-effectiveness of metformin as a public health intervention for the prevention of diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Prediabetic State
- Being tested
- Metformin, Lifestyle intervention
- Keywords
- diabetes, prevention, metformin, Mexico City
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
Lifestyle interventionBehavioural
The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Active comparator | The prediabetic individuals from the primary care centres that belong to this arm, will receive only recommendations for lifestyle modifications (physical activity and diet). Receives: Behavioral: Lifestyle intervention |
| Metformin | Active comparator | The prediabetic individuals from the primary care centres that belong to this arm, will receive metformin treatment and lifestyle modifications recommendations (physical activity and diet). Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes. measured by HbA1c and Fasting blood glucose (FBG)
We define type 2 diabetes (T2D) as either FBG 100-125 mg/dl or HbA1c of >= 6.5%
Measured: 3 years
Lifestyle modifications by decreasing adiposity indicators
We will evaluate this by : weight in Kg, height in mts. They also be combined to report BMI/m2, and waist circumference
Measured: Will be evaluated every 3 months during the 36 month period
Caloric intake
From food-frequency questionnaires.
Measured: Every 3 months during the 36 month period
Physical Activity
Expresses ad the average metabolic equivalents (METs)-hours/week
Measured: Every 3 months during the 36 month period
Secondary outcomes (4)
Implementation process outcomes at the clinic level. Using a questionnaire
Assess the implementation process outcomes at the clinic-, clinician- and patient-levels that will explain the observed effectiveness, and enable future efforts to adapt and disseminate the intervention model across other primary care settings. A questionnaire will be develop to assess the feasibility and limitations for the longterm implementation of this intervention
Measured: 5 years
Implementation process outcomes at the clinician level. Using a questionnaire
A questionnaire will be develop to assess the limitations of recruitment at the clinic . As well as to evaluate the feasibility of continuing this intervention in outside patients.
Measured: 5 years
Implementation process outcomes patient level. Assess via questionnaire
Assess the implementation process at the patient-levels using a questionnaire that show data regarding adherence to treatment and lifestyle modifications.
Measured: 5 years
Cost-utility of Metformin. Measured using cost per QALYS
Analyse the cost-utility of the implementation of this intervention in primary-care health. Using direct and indirect health-care cost data.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start10 Aug 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Primary health care clinics will be allocated to one of the two arms of the intervention. A) lifestyle modification, B) Metformin and lifestyle modification
- Masking
- None (open label)
- Enrolment
- 3,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ministry of Health, Mexico City, University of California, San Francisco
- Responsible party
- Principal investigator, Simon Barquera, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Simón Barquera, MD, PhD, Principal investigator, Instituto Nacional de Salud Pública
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194009
- Sponsor's protocol ID
- 102/100/00/16
- Acronym
- PRuDENTE
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez LA, Barquera S, Aguilar-Salinas CA, Sepulveda-Amor J, Sanchez-Romero LM, Denova-Gutierrez E, Balderas N, Moreno-Loaeza L, Handley MA, Basu S, Lopez-Arellano O, Gallardo-Hernandez A, Schillinger D. Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City). Contemp Clin Trials. 2020 Aug;95:106067. doi: 10.1016/j.cct.2020.106067. Epub 2020 Jun 21.
PubMed 32580032
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.
- ClinicalTrials.gov ID
- NCT03194009
- Acronym / sponsor ID
- PRuDENTE / 102/100/00/16
- Conditions
- Diabetes Mellitus, Type 2, Prediabetic State
- Keywords
- diabetes, prevention, metformin, Mexico City
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,060 participants (estimated)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ministry of Health, Mexico City, University of California, San Francisco
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Jun 2017 (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.
The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.
Detailed description
Diabetes in Mexico is considered a national emergency given its high prevalence, incidence, mortality and costs. Mexico has one of the highest prevalence of diabetes; in only 6 years (2000 to 2006) this prevalence increased from 7.5% to 14.4%. In 2015, 151 deaths per 100,000 inhabitants occurred in Mexico due to diabetes complications.
Metformin is a hypoglycemia drug and it´s the first line medication for the treatment of type 2 diabetes.There is currently a significant amount of evidence that metformin administration reduces the progression from pre-diabetes to diabetes and, despite its monotherapy being less effective than lifestyle changes, the good biosafety profile and low cost have made it the drug of choice in a joint treatment.
The PRuDENTE study proposes to perform this intervention in a real environment in the clinics of the first level of care of the Ministry of Health of the Government of Mexico City, in order to provide evidence about the cost-effectiveness of metformin as a public health intervention for the prevention of diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Primary health care clinics will be allocated to one of the two arms of the intervention. A) lifestyle modification, B) Metformin and lifestyle modification
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Active comparator | Behavioral: Lifestyle interventionThe prediabetic individuals from the primary care centres that belong to this arm, will receive only recommendations for lifestyle modifications (physical activity and diet). |
| Metformin | Active comparator | Drug: MetforminThe prediabetic individuals from the primary care centres that belong to this arm, will receive metformin treatment and lifestyle modifications recommendations (physical activity and diet). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having received primary care in the chosen health center (ideally two or more visits to that clinic in the prior year).
- Subscribers to "Seguro Popular" ( Mexican national health insurance)
- Body mass index >=30 kg / m2
- Results of fasting serum glucose with values for pre-diabetes diagnosis (glucose between 100 and 125 mg / dl)
- Family history of DMT2 (1st grade relative).
Key exclusion criteria (7 listed)
- Renal insufficiency (Glomerular Filtration Rate (GFR) <30 ml/min).
- Known hepatic impairment or altered liver enzymes (aspartate aminotransferase (AST) AST or alanine aminotransferase (ALT) three times above normal values)
- Active alcoholism or drug addiction
- Allergies or previous known intolerance to exercise or metformin.
- Current 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 |
|---|---|---|
| MetforminThe patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations | Drug | Metformin |
| Lifestyle interventionThe patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes | Behavioural | Lifestyle Intervention |
Primary outcome
Diabetes. measured by HbA1c and Fasting blood glucose (FBG)
Time frame: 3 years
We define type 2 diabetes (T2D) as either FBG 100-125 mg/dl or HbA1c of >= 6.5%
Lifestyle modifications by decreasing adiposity indicators
Time frame: Will be evaluated every 3 months during the 36 month period
We will evaluate this by : weight in Kg, height in mts. They also be combined to report BMI/m2, and waist circumference
Caloric intake
Time frame: Every 3 months during the 36 month period
From food-frequency questionnaires.
Physical Activity
Time frame: Every 3 months during the 36 month period
Expresses ad the average metabolic equivalents (METs)-hours/week
4 secondary outcomes
Implementation process outcomes at the clinic level. Using a questionnaire
Time frame: 5 years
Implementation process outcomes at the clinician level. Using a questionnaire
Time frame: 5 years
Implementation process outcomes patient level. Assess via questionnaire
Time frame: 5 years
Cost-utility of Metformin. Measured using cost per QALYS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 32580032Rodriguez LA, Barquera S, Aguilar-Salinas CA, Sepulveda-Amor J, Sanchez-Romero LM, Denova-Gutierrez E, Balderas N, Moreno-Loaeza L, Handley MA, Basu S, Lopez-Arellano O, Gallardo-Hernandez A, Schillinger D. Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City). Contemp Clin Trials. 2020 Aug;95:106067. doi: 10.1016/j.cct.2020.106067. Epub 2020 Jun 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Simón Barquera, MD, PhD principal investigator
Instituto Nacional de Salud Pública
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Lifestyle intervention in people with Diabetes Mellitus, Type 2 and Prediabetic State, run by Instituto Nacional de Salud Publica, 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luz María Sánchez-Romero, MD, PhD (+52 (55) 54871000 ext. 4144, luz.sanchez@insp.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes. measured by HbA1c and Fasting blood glucose (FBG) (time frame: 3 years). The study lists 4 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 NCT03194009, which also lists 1 linked publication.
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 7 Mar 2018.