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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo of calcined magnesia, capsules |
|
| Pantoprazole | Experimental | The pantoprazole will be administered in 40mg capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days. |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin A1C | Change from Baseline in glycated hemoglobin A1C at 45 day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Gonzalez, PhD | Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano del Seguro Social. Hospital de Especialidades. | Guadalajara | Jalisco | 44380 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25704601 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pantoprazole | The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days |
| FG001 | Placebo | Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pantoprazole | The pantoprazole will be administered in 40mg capsules |
| BG001 | Placebo | Placebo of calcined magnesia, capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial | Posted | Mean | Standard Deviation | µU/ml | Change from Baseline at 45 days. (plus or minus 3 days) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pantoprazole | The pantoprazole will be administered in 40mg capsules |
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The intervention time was short to evaluate a total change in the primary outcome variables
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD. Manuel González Ortiz | Instituto Mexicano del Seguro Social | 33 36176000 | 31494 | uiec@prodigy.net.mx |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| placebo | Drug | Placebo 40 mg dose. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Glycated Hemoglobin A1C | Posted | Mean | Standard Deviation | percentage | Change from Baseline in glycated hemoglobin A1C at 45 day. |
|
|
|
| Primary | Second Phase of Insulin Secretion | Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days) | Posted | Mean | Standard Deviation | µU/ml | Baseline and 45 day |
|
|
|
| Primary | Total Insulin Secretion | The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion | Posted | Mean | Standard Deviation | µU/ml | Change from baseline of total insulin secretion at 45 day (plus or minus 3 days) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo | Placebo of calcined magnesia, capsules | 0 | 7 | 0 | 7 |
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| D006946 | Hyperinsulinism |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |