Type 2 Diabetes Clinical Trial
Official title:
Effect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes
The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.
Type 2 diabetes mellitus (T2DM) has become a major health problem worldwide with a high
prevalence and related mortality, and a high rate of disability in the economically active.
In Mexico the prevalence was 14.4% reported one of the highest in Latin America and
estimated a cost of $ 778 million allocated for this disease in 2010, i.e., the tenth place
worldwide. Within its pathophysiology are alterations in the secretion and insulin action,
qualitatively and quantitatively, which implies a challenge for long-term metabolic control
with the pharmacological arsenal available today. Since the function of pancreatic β cell
decreases as a function of time and lack of control is essential metabolic find drugs that
can preserve pancreatic cell mass and even promote neogenesis, with the aim of restoring the
physiological secretion of insulin have been lost in the early stages of type 2 diabetes to
achieve optimal glycemic control sustained over time to avoid complications and reduce the
costs associated with the disease.
Have been evaluated in animal models with promising results Proton Pumps Inhibitors (PPI)
for the restoration of glucose and the preservation of pancreatic cell function, including
promoting its growth through increased levels of gastrin, which appears to act as a growth
factor. However, at present no such mechanisms have been evaluated in humans, it would be
interesting to assess the effect of administration of a PPI such as pantoprazole is, on the
phases of insulin secretion in patients with T2DM recent diagnosis.
Material and Methods: Randomized, double-blind, placebo controlled clinical trial.
Population: 14 drug-naive adults patients with T2DM and obesity.
Hyperglycemic-hyperinsulinemic clamp to assess the phases of insulin secretion. Intervention
for 45 days: pantoprazole 40mg or placebo.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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