PRuDENTE; Diabetes Prevention Via Exercise Nutrition and Treatment

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    3060
  • sponsor
    Instituto Nacional de Salud Publica, Mexico
Updated on 22 January 2021
diabetes
body mass index
hypertension
fasting
type 2 diabetes mellitus
metformin
antihypertensive drugs
dyslipidemia
prediabetic state
diabetes prevention
gestational diabetes

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.

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 its 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.

Details
Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), Prediabetes, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, pre-diabetic, prediabetic state, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Metformin, Lifestyle intervention
Clinical Study IdentifierNCT03194009
SponsorInstituto Nacional de Salud Publica, Mexico
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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