| Trial ID: | L6316 |
| Source ID: | NCT03194009
|
| Associated Drug: |
Metformin
|
| Title: |
PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment
|
| Acronym: |
PRuDENTE
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Prediabetic State
|
| Interventions: |
DRUG: Metformin|BEHAVIORAL: Lifestyle intervention
|
| Outcome Measures: |
Primary: 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%, 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, Will be evaluated every 3 months during the 36 month period|Caloric intake, From food-frequency questionnaires., Every 3 months during the 36 month period|Physical Activity, Expresses ad the average metabolic equivalents (METs)-hours/week, Every 3 months during the 36 month period | Secondary: 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, 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., 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., 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., 5 years
|
| Sponsor/Collaborators: |
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
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
3060
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2017-08-10
|
| Completion Date: |
2022-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2018-03-07
|
| Locations: |
Centros de Salud. SecretarÃa de Salud Ciudad de México, Mexico City, 06820, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT03194009
|
