Pantoprazole on Insulin Secretion in Diabetes
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Type 2 Diabetes |
Intervention | Drug: Pantoprazole Drug: placebo |
Phase | Phase 2/Phase 3 |
Sponsor | Coordinación de Investigación en Salud, Mexico |
Responsible Party | Coordinación de Investigación en Salud, Mexico |
ClinicalTrials.gov Identifier | NCT01541735 |
First Received | February 20, 2012 |
Last Updated | January 7, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 20, 2012 |
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Last Updated Date | January 7, 2014 |
Start Date | January 2012 |
Estimated Primary Completion Date | May 2013 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Glycated Hemoglobin A1C [Time Frame: Change from Baseline in glycated hemoglobin A1C at 45 day.] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Pantoprazole on Insulin Secretion in Diabetes |
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Official Title | Effect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes |
Brief Summary | 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 | 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 |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | 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. Other Names: PantozolDrug: placebo Placebo 40 mg dose. Other Names: placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 14 |
Estimated Completion Date | May 2013 |
Estimated Primary Completion Date | March 2013 |
Eligibility 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. |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01541735 |
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Other Study ID Numbers | IBP1301-93 |
Has Data Monitoring Committee | Yes |
Information Provided By | Coordinación de Investigación en Salud, Mexico |
Study Sponsor | Coordinación de Investigación en Salud, Mexico |
Collaborators | Not Provided |
Investigators | Principal Investigator: Manuel Gonzalez, PhD Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Instituto Mexicano del Seguro Social. Hospital de Especialidades. | Guadalajara, Jalisco, Mexico, 44380 |
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