Puberty: >Tanner 2 Breast Development or Testis >4ml, Type 1 Diabetes
Conditions
Brief summary
Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.
Interventions
DRUGRosiglitazone
Sponsors
Sydney Children's Hospitals Network
National Health and Medical Research Council, Australia
Novo Nordisk A/S
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Inclusion criteria
* T1DM duration \> 1year * age 10-18years * HbA1c \> 8% * puberty \> Tanner stage 2 breast or testis \>4ml
Exclusion criteria
* known non-compliance * hypo unaware
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| frequency of severe hypoglycaemia | — |
| insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp | — |
| weight | — |
| insulin dose | — |
| skin fold thickness | — |
| cholesterol | — |
| adiponectin | — |
| BMI-SDS | — |
Countries
Australia
Outcome results
None listed