Pantoprazole on Insulin Secretion in Diabetes (IBP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel Gonzalez Ortiz, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01541735
First received: February 20, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Pantoprazole
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • First Phase of Insulin Secretion [ Time Frame: Change from Baseline at 45 days. (plus or minus 3 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 45 day ] [ Designated as safety issue: No ]
    Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)

  • Total Insulin Secretion [ Time Frame: Change from baseline of total insulin secretion at 45 day (plus or minus 3 days) ] [ Designated as safety issue: No ]
    The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion


Secondary Outcome Measures:
  • Glycated Hemoglobin A1C [ Time Frame: Change from Baseline in glycated hemoglobin A1C at 45 day. ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo of calcined magnesia, capsules
Drug: placebo
Placebo 40 mg dose.
Other Name: placebo
Experimental: Pantoprazole
The pantoprazole will be administered in 40mg capsules
Drug: Pantoprazole
The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.
Other Name: Pantozol

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541735

Locations
Mexico
Instituto Mexicano del Seguro Social. Hospital de Especialidades.
Guadalajara, Jalisco, Mexico, 44380
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Manuel Gonzalez, PhD Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica
  More Information

No publications provided

Responsible Party: Manuel Gonzalez Ortiz, Principal Investigator, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01541735     History of Changes
Other Study ID Numbers: IBP1301-93
Study First Received: February 20, 2012
Results First Received: July 27, 2013
Last Updated: January 7, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Diabetes
Insulin
Pantoprazole

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Pantoprazole
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014