Type 2 Diabetes
Conditions
Keywords
Diabetes, Insulin, Pantoprazole
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.
Interventions
DRUGPantoprazole
The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.
DRUGplacebo
Placebo 40 mg dose.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Phase of Insulin Secretion | Change from Baseline at 45 days. (plus or minus 3 days) | 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 | Baseline and 45 day | Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days) |
| Total Insulin Secretion | Change from baseline of total insulin secretion at 45 day (plus or minus 3 days) | The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion |
Secondary
| Measure | Time frame |
|---|---|
| Glycated Hemoglobin A1C | Change from Baseline in glycated hemoglobin A1C at 45 day. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pantoprazole The pantoprazole will be administered in 40mg capsules | 7 |
| Placebo Placebo of calcined magnesia, capsules | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Placebo | Pantoprazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 46.2 years STANDARD_DEVIATION 9.6 | 49.8 years STANDARD_DEVIATION 7.1 | 48.0 years STANDARD_DEVIATION 8.39 |
| Region of Enrollment Mexico | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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.
Time frame: Change from Baseline at 45 days. (plus or minus 3 days)
Population: The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | First Phase of Insulin Secretion | 13.8 µU/ml | Standard Deviation 5.5 |
| Placebo | First Phase of Insulin Secretion | 15.9 µU/ml | Standard Deviation 9.3 |
Primary
Second Phase of Insulin Secretion
Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)
Time frame: Baseline and 45 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | Second Phase of Insulin Secretion | 35.9 µU/ml | Standard Deviation 21.2 |
| Placebo | Second Phase of Insulin Secretion | 38.4 µU/ml | Standard Deviation 30.1 |
Primary
Total Insulin Secretion
The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion
Time frame: Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | Total Insulin Secretion | 29.0 µU/ml | Standard Deviation 15.8 |
| Placebo | Total Insulin Secretion | 31.5 µU/ml | Standard Deviation 23.4 |
Secondary
Glycated Hemoglobin A1C
Time frame: Change from Baseline in glycated hemoglobin A1C at 45 day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pantoprazole | Glycated Hemoglobin A1C | 7.5 percentage | Standard Deviation 0.38 |
| Placebo | Glycated Hemoglobin A1C | 7.8 percentage | Standard Deviation 0.45 |