Clinical trial NCT01541735: Pantoprazole on Insulin Secretion in Diabetes
Official title: Effect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes
Insulin
Pantoprazole
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2012-03-01
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: First Phase of Insulin Secretion
timeFrame: Change from Baseline at 45 days. (plus or minus 3 days)
measure: Second Phase of Insulin Secretion
timeFrame: Baseline and 45 day
measure: Total Insulin Secretion
timeFrame: Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)
Secondary outcomes:
measure: Glycated Hemoglobin A1C
timeFrame: Change from Baseline in glycated hemoglobin A1C at 45 day.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Mexicano del Seguro Social. Hospital de Especialidades.
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica
name: Manuel Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.