PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead 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
• Treatments: Metformin

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