Glucocorticoid Induced Hyperglycemia Clinical Trial
Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity. However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will improve glucose metabolism in patients with high risk for diabetes morbidity, treated with glucocorticoids.
| Status | Not yet recruiting |
| Enrollment | 36 |
| Est. completion date | |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Planned treatment with T. Prednisone in dosage >0.5 mg/kg for two weeks or more. - Age >18 years - Body mass index >27 kg/m2 OR 1st degree relative with type 2 diabetes mellitus OR hypertension OR hyperlipidemia OR gestational diabetes in the past OR diagnosis of polycystic ovary syndrome. Exclusion criteria: - Glycosylated hemoglobin A1c >6.5% - Diagnosis of diabetes mellitus or treatment with anti-glycemic drug - Pancreatitis (acute or chronic) in the past - Active malignancy - Medullary thyroid carcinoma or multiple endocrine neoplasm type 2 of the patient or of 1st degree relative - Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center, Beilinson Campus | Petah Tiqva |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose levels 2 hours after 75 gr OGTT | 6 weeks | No |