CharacterIzation of Adult Onset Autoimmune Diabetes (CIAO)

July 21, 2023 updated by: AdventHealth Translational Research Institute
The purpose of the study is to identify new biomarkers of Adult Onset Autoimmune Diabetes (AOnAD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Normal Volunteers (HNV)
Other: Mixed Meal Test
a standard liquid mixed meal will be administered to the participant. The test meal with 1 kcal/ml and with the following caloric distribution Protein: 25%, Carbohydrate: 53%, Fat: 22% is given at a dose of 6 mL per kilogram body weight. Maximum dose is 360 mL and it will be ingested over 5 minutes. Blood samples will be taken 10 min prior to ingestion (t=-10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 minutes.
Other: Dual Energy X-Ray Absorptiometry (DEXA)
DEXA Scans will be performed to obtain body composition measures (body fat and estimated muscle mass) using a General Electric (GE) Lunar iDXA whole-body scanner.
Procedure: Adipose Tissue Biopsy
The abdominal skin 6-10 cm lateral to the umbilicus will be cleansed with chlorhexidine. A sterile drape is placed, and the skin and adipose tissue will be anesthetized using Lidocaine. A 3-4 mm Mercedes Liposuction cannula will be inserted for aspiration of up to 2g of adipose tissue.
Type 2 Diabetes
Other: Mixed Meal Test
a standard liquid mixed meal will be administered to the participant. The test meal with 1 kcal/ml and with the following caloric distribution Protein: 25%, Carbohydrate: 53%, Fat: 22% is given at a dose of 6 mL per kilogram body weight. Maximum dose is 360 mL and it will be ingested over 5 minutes. Blood samples will be taken 10 min prior to ingestion (t=-10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 minutes.
Other: Dual Energy X-Ray Absorptiometry (DEXA)
DEXA Scans will be performed to obtain body composition measures (body fat and estimated muscle mass) using a General Electric (GE) Lunar iDXA whole-body scanner.
Procedure: Adipose Tissue Biopsy
The abdominal skin 6-10 cm lateral to the umbilicus will be cleansed with chlorhexidine. A sterile drape is placed, and the skin and adipose tissue will be anesthetized using Lidocaine. A 3-4 mm Mercedes Liposuction cannula will be inserted for aspiration of up to 2g of adipose tissue.
Adult Onset Autoimmune Diabetes/Latent Autoimmune Diabetes
Other: Mixed Meal Test
a standard liquid mixed meal will be administered to the participant. The test meal with 1 kcal/ml and with the following caloric distribution Protein: 25%, Carbohydrate: 53%, Fat: 22% is given at a dose of 6 mL per kilogram body weight. Maximum dose is 360 mL and it will be ingested over 5 minutes. Blood samples will be taken 10 min prior to ingestion (t=-10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 minutes.
Other: Dual Energy X-Ray Absorptiometry (DEXA)
DEXA Scans will be performed to obtain body composition measures (body fat and estimated muscle mass) using a General Electric (GE) Lunar iDXA whole-body scanner.
Procedure: Adipose Tissue Biopsy
The abdominal skin 6-10 cm lateral to the umbilicus will be cleansed with chlorhexidine. A sterile drape is placed, and the skin and adipose tissue will be anesthetized using Lidocaine. A 3-4 mm Mercedes Liposuction cannula will be inserted for aspiration of up to 2g of adipose tissue.
Type 1 Diabetes
Other: Mixed Meal Test
a standard liquid mixed meal will be administered to the participant. The test meal with 1 kcal/ml and with the following caloric distribution Protein: 25%, Carbohydrate: 53%, Fat: 22% is given at a dose of 6 mL per kilogram body weight. Maximum dose is 360 mL and it will be ingested over 5 minutes. Blood samples will be taken 10 min prior to ingestion (t=-10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 minutes.
Other: Dual Energy X-Ray Absorptiometry (DEXA)
DEXA Scans will be performed to obtain body composition measures (body fat and estimated muscle mass) using a General Electric (GE) Lunar iDXA whole-body scanner.
Procedure: Adipose Tissue Biopsy
The abdominal skin 6-10 cm lateral to the umbilicus will be cleansed with chlorhexidine. A sterile drape is placed, and the skin and adipose tissue will be anesthetized using Lidocaine. A 3-4 mm Mercedes Liposuction cannula will be inserted for aspiration of up to 2g of adipose tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood collection
Time Frame: Screening Visit and Day 1
A change in the levels of specific microRNAs (miRNA) isolated from circulating exosomes.
Screening Visit and Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Anna Casu, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Actual)

November 12, 2021

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1437923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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