Pantoprazole on Insulin Secretion in Diabetes

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

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo of calcined magnesia, capsules | Drug: placebo<br>* Placebo 40 mg dose.<br>|
| Experimental: Pantoprazole<br>The pantoprazole will be administered in 40mg capsules | Drug: Pantoprazole<br>* The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.<br>* Other names: Pantozol;|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated Hemoglobin A1C |  | Change from Baseline in glycated hemoglobin A1C at 45 day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin, Pantoprazole