Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CharacterIzation of Adult Onset Autoimmune Diabetes (CIAO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971955
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

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

Condition or disease Intervention/treatment
Diabetes Other: Mixed Meal Test Other: Dual Energy X-Ray Absorptiometry (DEXA) Procedure: Adipose Tissue Biopsy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: CharacterIzation of Adult Onset Autoimmune Diabetes
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 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.

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.

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971955


Contacts
Layout table for location contacts
Contact: Recruitment Department 407-303-7100 fh.tri@flhosp.org

Locations
Layout table for location information
United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    fh.tri@flhosp.org   
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
Layout table for investigator information
Principal Investigator: Anna Casu Study Principal Investigator

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT03971955     History of Changes
Other Study ID Numbers: 1437923
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases