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Completed

NCT Number: NCT01541735

Pantoprazole on Insulin Secretion in Diabetes

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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Instituto Mexicano del Seguro Social. Hospital de Especialidades.

Guadalajara, Jalisco, 44380, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pantoprazole

Drug

The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.

Other names: Pantozol

Placebo

Drug

Placebo 40 mg dose.

Primary outcomes

  1. First Phase of Insulin Secretion

    Time frame: 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.

  2. Second Phase of Insulin Secretion

    Time frame: Baseline and 45 day

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

  3. Total Insulin Secretion

    Time frame: 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

Secondary outcomes

  1. Glycated Hemoglobin A1C

    Time frame: Change from Baseline in glycated hemoglobin A1C at 45 day.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

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

Acronym: IBP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2012
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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