Pantoprazole on Insulin Secretion in Diabetes (IBP)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: placebo; Drug: Pantoprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44380
      • Instituto Mexicano del Seguro Social. Hospital de Especialidades.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo of calcined magnesia, capsules	Drug: placebo; Placebo 40 mg dose.
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 Names: Pantozol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Glycated Hemoglobin A1C	Change from Baseline in glycated hemoglobin A1C at 45 day.

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Gonzalez-Ortiz M, Martinez-Abundis E, Mercado-Sesma AR, Alvarez-Carrillo R. Effect of pantoprazole on insulin secretion in drug-naive patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Apr;108(1):e11-3. doi: 10.1016/j.diabres.2015.01.039. Epub 2015 Feb 7.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 21, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Pantoprazole
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: IBP1301-93