Scientists hunt for hidden clues in adult diabetes
NCT ID NCT03971955
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find new biological markers (biomarkers) for Adult Onset Autoimmune Diabetes (AOnAD) by analyzing blood samples from 25 adults with type 1 diabetes. Researchers will measure changes in specific microRNAs from tiny particles in the blood. No treatment is given; the goal is to better understand the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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25 people
The number who actually took part.
- Started
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Jul 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This is an observational cross-sectional pilot study that will compare 4 groups of 10 participants each (5±1 of each gender per group) affected by AOnAD, T2D, T1D and Healthy Normal Volunteers (HNV). They will be characterized clinically and biochemically.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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) * age 40-75 years * BMI 25 to 35 kg/m2 with a stable body weight (±3 kg in the past 6 months) * No personal history of diabetes according to ADA criteria * No history of diabetes in first degree relatives (FDRs) * Fasting C-peptide levels \> 0.3 nmol/l * IAAbs are Insulin AutoAntibodies (IAA), Thyrosine phosphatase IA-2 Antibodies (IA-2 Ab), Glutamic Acid Decarboxylase Antibodies (GAD Ab), Zinc Transporter 8 Antibodies (ZnT8 Ab), Islet Cell Antibodies (ICA). Exclusion Criteria: * 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) * Gastrointestinal disorders associated with malabsorption. * Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection. * Had major surgery within 4 weeks prior to the pre-trial (screening) visit * Participation in studies involving investigational drug(s) within 30 days prior to Screening Visit 1 * Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening Visit * Allergies to milk derived or soy derived products, lactose intolerance (due to the composition of the standard liquid meal that will be used for the test) * Allergies and reactions to lidocaine. * History of eating disorders * Psychiatric disease prohibiting adherence to study protocol * Unable to provide a reliable informed consent * Presence of any condition that, in the opinion of the investigator and clinical team, compromises participant safety or data integrity or the participant's ability to complete study visits
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804, United States
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Other studies related to the condition(s) this trial covers.
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