Pantoprazole on Insulin Secretion in Diabetes

Type 2 Diabetes Clinical Trial

— IBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541735
• Other study ID #: IBP1301-93
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 20, 2012
• Last updated: January 7, 2014
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Pantoprazole
The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.
• placebo
Placebo 40 mg dose.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social. Hospital de Especialidades.	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Primary	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)	No
Secondary	Glycated Hemoglobin A1C		Change from Baseline in glycated hemoglobin A1C at 45 day.	No