Adult late-onset autoimmune diabetes
Conditions
Interventions
Hydroxychloroquine group:Treatment combined with hydroxychloroquine sulfate tables
Control group:Conventional therapy
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Meet the diagnostic criteria for latent autoimmune diabetes in adults (Chinese expert consensus on the diagnosis and treatment of latent autoimmune diabetes in Adults (2021 edition)) : LADA was diagnosed if the following three items were present a) age of onset >=18 years old; b) positive islet autoantibodies or islet autoimmune T cells; c) insulin-independent for at least half a year after diabetes diagnosis. B. aged 18-70 years; C. History of diabetes =200pmol/L.
Exclusion criteria
Exclusion criteria: 1.Severe ketoacidosis; 2.Existing retinopathy; 3.Existing macular degeneration; 4.Abnormalities in the heart conduction system, including: sinoatrial block, atrioventricular block, bundle branch block and so on. 5.Electrocardiogram indicates prolonged QT interval; 6.Electrocardiogram suggests ventricular arrhythmia; 7.Taking amiodarone; 8.Electrocardiogram suggests sinus bradycardia; 9.History of myocarditis, smyocarditis ymptoms, or elevated myocardial enzymes; 10.Doppler ultrasound indicates ventricular enlargement; 11.proBNP > 2 times of the upper limit of normal value; 12.Cardiovascular events in the last 1 year; 13.Cardiovascular surgery in the last 1 year; 14.Abnormal liver function, ALT > 3 times of the upper limit of normal value, AST > 3 times of the upper limit of normal value; 15.Suffering from liver disease; 16.Suffering from severe kidney disease or blood creatinine > 1.5mg/dl (132.6umol/L) or eGFR < 60mL/min/1.73m^2; 17.Suffering from serious underlying diseases, such as heart failure, lung failure, malignant tumors, etc; 18.With hypokalemia; 19.With hypomagnesemia; 20.Suffering from psoriasis or having a history of psoriasis or suffering from other skin conditions; 21.Suffering from porphyria; 22.Suffering from lactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome; 23.Taking tricyclic antidepressants; 24.Taking antipsychotic drugs; 25.Taking moxifloxacin; 26.Taking halofantraline; 27.Taking tamoxifen; 28.Be allergic to 4-aminoquinoline compounds; 29.Effective contraception cannot be taken during the trial; 30.Women during pregnancy; 31.Female lactating; 32.Conceive in the coming 2 years; 33.Evidence of any other autoimmune diseases; 34.Insulin requirement of more than 0.8 U/kg/d; 35.Evidence of chronic or acute infection; 36.Patients unable to follow the treatment protocol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glutamic acid decarboxylase antibody titer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine pregnancy test;Urinary cast;Urine protein;Urinary leukocytes;Symptoms of visual abnormalities;Ophthalmology physical examination;Visual field;Retinal and maculopathy;Corneal diseases;Neurological symptoms;Physical examination of the nervous system;Dermal symptoms;Physical examination of the skin system;Gastrointestinal symptom;Non-specific symptoms;WBC;Neutrophil count;Lymphocyte count;Red blood cell count;Hemoglobin concentration;Blood platelet count;Serum alanine aminotransferase;Serum glutamic-oxaloacetic transaminase;Urine ketone;Fasting C-peptide level;IL-8;IL-10;IL-12;INF-a;INF-?;Count of T lymphocyte subsets;Count of B cells and NK cells;Count of Treg cells;Serum complement;Complement 1 inhibitor;Quantification of immunoglobulin;Hypoglycemic events;Circulatory Symptoms;CK-MB;LDH;proBNP;Incidence of arrhythmia;Incidence of Ventricular hypertrophy;The percentage of patients achieving the target glycated hemoglobin level;Basal Insulin dose;Mealtime insulin dose;Daily insulin dose;Time in range (TIR);Time above range (TAR);Time blow range (TBR);Coefficient of Variation (CV);hsCRP;TNF-a;IL-1ß;IL-2;IL-6;Homa islet (CP-DM);Blood urea nitrogen;Serum creatinine;Estimated glomerularfiltrationrate (eGFR); | — |
Countries
China
Contacts
Public ContactJiao Yang
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed