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Clinical Trial Details

Trial ID: L2868
Source ID: NCT03682640
Associated Drug: Azithromycin Monohydrate
Title: Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
Acronym: AIDIT
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Diabetes Mellitus|Metabolic Disease|Glucose Metabolism Disorders|Endocrine System Diseases|Juvenile Diabetes|Insulin Dependent Diabetes|Type 1 Diabetes Mellitus|Inflammation|Diet Modification
Interventions: DRUG: Azithromycin Monohydrate|DRUG: Insulin Lispro|BEHAVIORAL: Dietician support
Outcome Measures: Primary: Stimulated C-peptide during an MMTT, Residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide two-hour under the curve profile measured one year after study inclusion., 12 months after inclusion | Secondary: >60% of time in target blood glucose levels, Proportion of subjects with time in target 3.9-7.8 mmol/L ≥ 60% and with a glycaemic variability expressed as standard deviation \< 2 mmol/L according to continuous glucose monitoring during two weeks in the 12th month after initiation of the study treatment., two weeks in the 12th month after initiation of the study treatment|Time in target blood glucose levels, Time in target (3.9-7.8 mmol/L) during 30 days in the 12th month after initiation of the study treatment., 30 days in the 12th month after initiation of the study treatment|Time in range blood glucose levels, Time in range (3.9-10 mmol/L) during 30 days in the 12th month after initiation of the study treatment., 30 days in the 12th month after initiation of the study treatment|Insulin dose, Mean daily insulin dosage per kilo bodyweight during 30 days in the 12th month after initiation of the study treatment., 30 days in the 12th month after initiation of the study treatment|HbA1c levels, HbA1c at 12 months after study initiation, 12 months|Hypoglycaemic events, Number of severe hypoglycaemic events (hypoglycaemia level 3) during the study year., From study start to 12 months|Time in hypoglycemic range, Time in hypoglycaemic range level 1 and 2 (\<3.9 mmol/l and \<3.0 mmol/l) respectively in CGM registrations during 30 days in the 12th month after initiation of the study treatment., 30 days in the 12th month|IDAA1c, Insulin-dose-adjusted HbA1c (IDAA1c) 12 months after study initiation, 12 months|Pro-insulin/c-peptide, Pro-insulin/c-peptide ratio in serum 12 months after study initiation, 12 months|Pancreas inflammation, Inflammation in the pancreas measured by contrast enhanced MRI at 12 months after initiation of the study, 12 months|QoL, Health related Quality of Life; Varni PedsQL, Generic and Diabetes specific questionnaire, by child and proxy (parents or other caregivers) at study start and 12 months after study initiation., 12 months|Gastrointestinal symptoms, Questionnaire on gastrointestinal symptoms: "The gastrointestinal symptom rating scale" (GSRS) at study start and 12 months after study initiation ., 12 months|Time spent eating, Average time spent eating at meals during four days in the 12th month after initiation of the study treatment., 12 months|Intake of saturated fat, Intake of saturated fat (E% and if the child reaches Nordic Nutritional Recommendations, NNR) during four days in the 12th month after initiation of the study treatment., four days in the 12th month|Intake of fruit, Intake of fruit and vegetables (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment., four days in the 12th month|Intake of macronutrients, Intake of macronutrients (E% and g/day) during four days in the 12th month after initiation of the study treatment., four days in the 12th month|Intake of fibre, Intake of fibre (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment., four days in the 12th month|Physical activity measured with accelerometer, Physical activity registered with accelerometer during one week in the 6th month after initiation of the study treatment., 6 months|Physical activity measured with accelerometer, Physical activity registered with accelerometer during one week in the 12th month after initiation of the study treatment., 12 months|Oral microbiome, The oral microbiome at 12 months after study initiation., 12 months|Change in stimulated C-peptide, Change in stimulated c-peptide two-hour under the curve profile from 6 weeks to 12 months after initiation of study treatment., change from 6 weeks to 12 months after initiation of study treatment
Sponsor/Collaborators: Sponsor: Uppsala University | Collaborators: Göteborg University
Gender: ALL
Age: CHILD
Phases: PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09
Completion Date: 2021-12-31
Results First Posted:
Last Update Posted: 2018-09-24
Locations: The Queen Silvia Children's Hospital / Sahlgrenska University Hospital, Gothenburg, Sweden
URL: https://clinicaltrials.gov/show/NCT03682640