The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

Tufts University

Status

Completed

Conditions

Healthy

Treatments

Drug: cinacalcet

Study type

Interventional

Funder types

Other

Identifiers

NCT00336739

2455

Details and patient eligibility

About

The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.

Full description

The calcium sensing receptor (CaSR) was originally found on parathyroid and renal cells and more recently it has been identified on cells that regulate gastric acid secretion (G cells and parietal cells). However, its role in regulating acid secretion in humans is completely unknown and is of potential importance because an acid environment in the stomach enhances intestinal calcium absorption. In this pilot project, we will stimulate the CaSR with a CaSR-agonist called cinacalcet. Our hypothesis is that activation of the CaSR will in turn increase gastric acid production in healthy volunteers.

Enrollment

17 patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy ambulatory men and postmenopausal women
Age 45 to 70
Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.

Exclusion criteria

Ionized Ca++ level <4.39 mg/dl or >5.02 mg/dl (normal reference range 4.18- 5.02).
24-hour UCa++ excretion >350 mg.
Cr >1.3.
AST/ALT values >10% beyond reference range.
Hgb level <11.7 g/dl in women and <13.2 g/dl in men.
MCV level >102 UM3.
Basal acid output >5 mEq/h in men and >3.8 mEq/h in women.
Basal acid output <1 mEq/h in men and <0.2 mEq/h in women.
Age <45 or >70.
Premenopausal or <1 year post-menopause.
Individuals following vegan diets.
Current EtOH abuse.
Lidocaine allergy. Medications
Antacids
H2 blockers
Proton pump inhibitors
Carafate
Anticholinergic agents (i.e. TCA)
Cholinergic agents
Antihistamines in the last 3 weeks
Cogentin
Adrenergic blockers
Thiazide diuretics
Antiplatelet drugs
Oral and Inhaled Glucocorticoids
Bisphosphonates
Raloxifene, Tamoxifen
Tobacco
EtOH during study
rPTH
Calcitonin
Ketoconazole/Itraconazole
Calcitriol
Paricalcitol
Drisdol, Ergocalciferol
Phosphate binders
Anticoagulant
Erythromycin
Hormone replacement therapy except vaginal estrogen creams