Diabetes Mellitus Clinical Trial
Official title:
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
Increasing evidences suggest that infections are important etiological factors for the
development of Type 1 Diabetes (T1D). The overall hypothesis of the study is that the
treatment of children, during the first year after diagnosis of T1D with Azithromycin,
combined with repeated episodes of intensified insulin treatment to induce maximal beta-cell
rest, and dietician support to promote dietary habits that minimize the likelihood of
bacterial reflux from the duodenum to the pancreatic duct, will lead to preservation of beta
cell function.
This trial will examine whether the AIDIT protocol initiated within one week from diagnosis
could preserve insulin production in children with Type 1 Diabetes.
The study is a 2-arm, randomized, open, single center, clinical trial. Eligible patients with
type 1 diabetes will be randomized to the AIDIT protocol or treatment as usual (TAU).
All patients diagnosed with T1D and included in the study will receive standard of care. In
addition, the AIDIT protocol will include 1) treatment with Azithromycin for 52 weeks using a
protocol for children with cystic fibrosis, 2) repeated treatments with intensified
supervised high dose insulin infusion, and 3) extra advice and support from the study
dietician.
1. Azithromycin Azithromycin will be administered orally. Azithromycin will be given three
times per week for 52 weeks. The dose will be 500 mg for children with body weight ≥ 30
kg and 250 mg if body weight < 30 kg.
2. Intensified supervised high dose insulin infusions Participants will, in addition to
Azithromycin, also be subjected to intensified anti-diabetic treatment to achieve
increased beta-cell rest. This will be achieved by insulin lispro given as a supervised
iv infusion for 72 hours within one week of diagnosis and by subcutaneous infusion 6-8
hours during one day in study week 5, 9, 13, 17 (±1 week) and 25, 34, 43 (±2 weeks)
after inclusion. The intensified treatments will aim to target a blood glucose level of
4.0 ± 0.5 mmol/l. The efficacy of the intended maximal beta cell rest will be evaluated
by measurement of plasma glucose and endogenous C-peptide. If C-peptide remains positive
during the supervised infusion of insulin lispro this will be interpreted as that the
insulin dose needs to be increased at the next treatment occasion to achieve beta-cell
rest.
3. Dietician support Participants will receive extra advice and support from the study
dietician within the first week after randomization, and after 7 and 17 weeks.
Personalized nutritional advice on intake of carbohydrates, fat and protein based on
four-day food records will be given to in order to reduce insulin resistance and insulin
need in accordance with ISPAD guidelines. By giving nutritional advices on less volume
of the meals, especially of the fluid (maximum 300 ml per meal), and by trying to extend
the meal time to at least 20 minutes, the reflux into ductus pancreaticus might be
reduced.
All patients will be offered an examination of their pancreas with MRI at 0 and 12 months
after inclusion. In addition, plasma samples taken at inclusion and after 1.5 and 12 months
will be analysed for the presence of cell-free DNA indicating ongoing cell destruction.
Cell-specific methylation patterns of this cell-free DNA will be analysed to determine
cell-type specific cell death.
The effect of the addition of treatment according to the AIDIT protocol will be evaluated
with a Mixed Meal Tolerance Test (MMTT) to explore the effect on preservation of beta-cell
function.
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