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Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes

NCT03682640 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-24

No results posted yet for this study

Summary

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.

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

Azithromycin Monohydrate tablet (Azithromycin Sandoz) or oral suspension (Azithromax).

DRUG

Insulin Lispro

Solution for intravenous or subcutaneous use

BEHAVIORAL

Dietician support

Dietary advice

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Gun Forsander, MD, PhD · The Queen Silvia Children's Hospital /Sahlgrenska University Hospital (SU), Sahlgrenska Academy, Dept of Pediatrics, University of Gothenburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
72 Months
Max Age
192 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682640 on ClinicalTrials.gov