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PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment (PRuDENTE)

Primary Purpose

Diabetes Mellitus, Type 2, Prediabetic State

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Metformin

Lifestyle intervention

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, prevention, metformin, Mexico City

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Previous diagnosis of hypertension or dyslipidaemia.
Have received antihypertensive medication and / or for cholesterol / lipids.
History of gestational diabetes mellitus.

Exclusion Criteria:

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

Sites / Locations

Centros de Salud. Secretaría de Salud Ciudad de MéxicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Lifestyle Intervention

Metformin

Arm Description

The prediabetic individuals from the primary care centres that belong to this arm, will receive only recommendations for lifestyle modifications (physical activity and diet).

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).

Outcomes

Primary Outcome Measures

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%

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

Caloric intake

From food-frequency questionnaires.

Physical Activity

Expresses ad the average metabolic equivalents (METs)-hours/week

Secondary Outcome Measures

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

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.

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.

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.

Full Information

NCT ID

NCT03194009

First Posted

June 2, 2017

Last Updated

March 5, 2018

Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ministry of Health, Mexico City, University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT03194009

Brief Title

PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

Acronym

PRuDENTE

Official Title

Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 10, 2017 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ministry of Health, Mexico City, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Prediabetic State

Keywords

diabetes, prevention, metformin, Mexico City

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

3060 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle Intervention

Arm Type

Active Comparator

Arm Description

The prediabetic individuals from the primary care centres that belong to this arm, will receive only recommendations for lifestyle modifications (physical activity and diet).

Arm Title

Metformin

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle intervention

Intervention Description

The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes

Primary Outcome Measure Information:

Title

Diabetes. measured by HbA1c and Fasting blood glucose (FBG)

Description

We define type 2 diabetes (T2D) as either FBG 100-125 mg/dl or HbA1c of >= 6.5%

Time Frame

3 years

Title

Lifestyle modifications by decreasing adiposity indicators

Description

We will evaluate this by : weight in Kg, height in mts. They also be combined to report BMI/m2, and waist circumference

Time Frame

Will be evaluated every 3 months during the 36 month period

Title

Caloric intake

Description

From food-frequency questionnaires.

Time Frame

Every 3 months during the 36 month period

Title

Physical Activity

Description

Expresses ad the average metabolic equivalents (METs)-hours/week

Time Frame

Every 3 months during the 36 month period

Secondary Outcome Measure Information:

Title

Implementation process outcomes at the clinic level. Using a questionnaire

Description

Time Frame

5 years

Title

Implementation process outcomes at the clinician level. Using a questionnaire

Description

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.

Time Frame

5 years

Title

Implementation process outcomes patient level. Assess via questionnaire

Description

Assess the implementation process at the patient-levels using a questionnaire that show data regarding adherence to treatment and lifestyle modifications.

Time Frame

5 years

Title

Cost-utility of Metformin. Measured using cost per QALYS

Description

Analyse the cost-utility of the implementation of this intervention in primary-care health. Using direct and indirect health-care cost data.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Previous diagnosis of hypertension or dyslipidaemia. Have received antihypertensive medication and / or for cholesterol / lipids. History of gestational diabetes mellitus. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luz María Sánchez-Romero, MD, PhD

Phone

+52 (55) 54871000

Ext

4144

luz.sanchez@insp.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Alberto Gallardo, MD

Phone

+52 (55) 50381700

Ext

1597

albgallardo@yahoo.com.mx

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simón Barquera, MD, PhD

Organizational Affiliation

Instituto Nacional de Salud Pública

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centros de Salud. Secretaría de Salud Ciudad de México

City

Mexico City

ZIP/Postal Code

06820

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alberto Gallardo, MD

Phone

+52 (55) 50381700

Ext

1597

albgallardo@yahoo.com.mx

First Name & Middle Initial & Last Name & Degree

Carmen Vanegas, MD

Phone

+52(55) 50381700

Ext

1067

carmenvanegas_5@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32580032

Citation

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.

Results Reference

derived

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PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

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