CharacterIzation of Adult Onset Autoimmune Diabetes

AdventHealth Translational Research Institute1 site in 1 country25 target enrollmentJuly 8, 2019

ConditionsDiabetes

Overview

The purpose of the study is to identify new biomarkers of Adult Onset Autoimmune Diabetes (AOnAD).

Registry

clinicaltrials.gov

Start Date

July 8, 2019

End Date

December 2025

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

AdventHealth Translational Research Institute

Responsible Party

Sponsor

•Type 1 Diabetes (T1D)
•age 18-35 years
•age at diagnosis 13 to 30 years
•Body Mass Index (BMI) 25 to 35 kg/m2 with a stable body weight (±3 kg in the past 6 months)
•diagnosis of T1D according to American Diabetes Association (ADA) criteria continuously requiring insulin for survival (if in doubt, diagnosis can be confirmed by positivity of 2 or more IAAb\* at time of diagnosis, at any time or at time of recruitment)
•diabetes diagnosis performed within the previous 5 years,
•requiring insulin continuously since diagnosis to prevent ketosis
•Fasting C-peptide levels \< 0.3 nmol/l
•Type 2 Diabetes (T2D)
•age 40-75 years

•For T2D participants: treatment with insulin or with thiazolidinediones (TZDs).
•For T1D and AOnAD/LADA participants: treatment with TZDs.
•Presence of unstable cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)
•Evidence of acute or chronic liver disease even if asymptomatic (AST or ALT \>2.5 times the upper limit of normal)
•Kidney disease (creatinine \>1.6 mg/dl or estimated GFR\<60 ml/min)
•Triglycerides \>500 mg/dl, LDL \>200 mg/dl
•Uncontrolled hypertension (Blood Pressure BP\>160 mmHg systolic or \>100 mmHg diastolic)
•Recent important weight loss (\>3 kg in 3 months)
•History of drug or alcohol abuse (\> 3 drinks per day) within the last 5 years.
•History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).