Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes, Insulin dependent diabetes, Juvenile onset diabetes, pioglitazone
Brief summary
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.
Detailed description
Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.
Interventions
DRUGpioglitazone
Pioglitazone daily; dose varies with size
DRUGPlacebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type 1 diabetes mellitus diagnosed within 4 months * Age \> 6 years of age * Ability to swallow capsule * Signed informed consent / assent
Exclusion criteria
* Other illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-peptide response to a Sustacal meal | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Insulin requirement | 6 months |
| Hemoglobin A1c | 6 months |
Countries
United States
Outcome results
None listed