Pantoprazole on Insulin Secretion in Diabetes (IBP)
|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|
- 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
- Glycated Hemoglobin A1C [ Time Frame: Change from Baseline in glycated hemoglobin A1C at 45 day. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo of calcined magnesia, capsules
Placebo 40 mg dose.
The pantoprazole will be administered in 40mg capsules
The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.
Other Name: Pantozol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541735
|Instituto Mexicano del Seguro Social. Hospital de Especialidades.|
|Guadalajara, Jalisco, Mexico, 44380|
|Principal Investigator:||Manuel Gonzalez, PhD||Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica|