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临床试验/NCT01541735
NCT01541735已完成2 期

Effect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes

Coordinación de Investigación en Salud, Mexico1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
First Phase of Insulin Secretion

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo of calcined magnesia, capsules

干预措施: placebo (Drug)

Pantoprazole

Experimental

The pantoprazole will be administered in 40mg capsules

干预措施: Pantoprazole (Drug)

结局指标

主要结局

First Phase of Insulin Secretion

时间窗: 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

时间窗: Baseline and 45 day

Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)

Total Insulin Secretion

时间窗: 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

次要结局

  • Glycated Hemoglobin A1C(Change from Baseline in glycated hemoglobin A1C at 45 day.)

研究者

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Manuel Gonzalez Ortiz

Principal Investigator

Coordinación de Investigación en Salud, Mexico

研究点 (1)

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