Pantoprazole on Insulin Secretion in Diabetes

Phase 2

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: placebo
Drug: Pantoprazole

Registration Number: NCT01541735

Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief Summary: The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

Inclusion Criteria

Type 2 diabetes mellitus
Drug-Naive
No complications
HbA1c 7 to < 9%
Fasting plasma glucose < 210mg/dl
Body mass index 30.0 to 39.9 and body weight stable for at least 3 months before the study
Non smokers
Blood pressure < 130/80

Exclusion Criteria

Diabetes complications
Women pregnant or stage of lactation
Hepatic, renal, autoimmune disease
Take drugs with effects on insulin secretion
Zollinger-Ellison disease
Gastric or pancreatic tumor.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo of calcined magnesia, capsules
Pantoprazole	Pantoprazole	The pantoprazole will be administered in 40mg capsules

Primary Outcome Measures

Name	Time	Method
First Phase of Insulin Secretion	Change from Baseline at 45 days. (plus or minus 3 days)	The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.
Second Phase of Insulin Secretion	Baseline and 45 day	Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)
Total Insulin Secretion	Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)	The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion