CharacterIzation of Adult Onset Autoimmune Diabetes
Running, not enrolling
Conditions studied: Diabetes
In brief
The purpose of the study is to identify new biomarkers of Adult Onset Autoimmune Diabetes (AOnAD).
Key facts
- Study ID
- NCT03971955
- Run by
- AdventHealth Translational Research Institute
- People needed
- 25
- Starts
- 2019-07-08
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- age at diagnosis 40 to 70 years
- BMI 25 to 35 kg/m2 with a stable body weight (±3 kg in the past 6 months)
- diagnosis of diabetes according to ADA criteria
- Diabetes diagnosis performed within the previous 5 years
- Not requiring insulin
- Fasting C-peptide levels > 0.3 nmol/l
- Adult Onset Autoimmune Diabetes/Latent Autoimmune Diabetes of Adults (AOnAD/LADA)
- age 40-75 years
- age at diagnosis 40 to 70 years
- BMI 25 to 35 kg/m2 with a stable body weight (±3 kg in the past 6 months)
- diagnosis of diabetes according to ADA criteria
- fasting C-peptide > 0.3 nmol/l
- positive for at least one islet autoantibody (IAAb* - at time of diagnosis, at any time or at time of recruitment)
- not requiring insulin or, if on insulin, treatment started at least 6 months after diagnosis
- Healthy Normal Volunteers (HNV)
You may not qualify if…
- 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).
- History of organ transplant.
- History of bariatric surgery
- Bleeding or coagulation disorders requiring chronic use of blood thinners.
- Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for study procedures
- History of chronic pancreatitis or pancreatic surgery
- Acute or chronic infections
- History of HIV, active Hepatitis B or C, or Tuberculosis.
- Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) or other chronic hematology disorders.
- Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], etc.) other than the treatment for diabetes
- Thyroid dysfunction. Participants with a Thyroid Stimulating Hormone TSH > 10 µ IU or less than 0.4 µ IU are excluded. Participants on thyroid replacement medication or on antithyroid drugs may be enrolled providing they have been on a stable dose of medication for at least 6 weeks prior to screening and their TSH is within the range specified above.
- Severe asthma or chronic obstructive pulmonary disease
- Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to birth control or estrogen replacement therapy)
- Cushing's disease or syndrome
- Drugs that affect immune, weight or metabolic function, including but not limited to: oral corticosteroids, oral or injectable anti-obesity medications. Drugs for dyslipidemia (statins, ezetimibe, etc.) and a daily full strength or baby aspirin for atherosclerosis prevention will be allowed, provided patients have been on stable doses for at least 6 weeks prior to screening and that aspirin could be safely temporarily stopped for the study
- Weight >450 lbs. (This is Dual X-ray Absorptiometry (DEXA) table weight limit)
Where it is running
- Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.