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出境医 / 临床实验 / CharacterIzation of Adult Onset Autoimmune Diabetes (CIAO)

CharacterIzation of Adult Onset Autoimmune Diabetes (CIAO)

Study Description
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

Study Design
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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
Contacts and Locations

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
Tracking Information
First Submitted Date May 30, 2019
First Posted Date June 3, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date July 8, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019) 		Blood collection [ Time Frame: Screening Visit and Day 1 ]
A change in the levels of specific microRNAs (miRNA) isolated from circulating exosomes.
Original Primary Outcome Measures
 (submitted: May 30, 2019) 		Blood collection [ Time Frame: Screening Visit and Day 1 ]
A difference in the levels of specific microRNAs (miRNA) isolated from circulating exosomes.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CharacterIzation of Adult Onset Autoimmune Diabetes
Official Title CharacterIzation of Adult Onset Autoimmune Diabetes
Brief Summary The purpose of the study is to identify new biomarkers of Adult Onset Autoimmune Diabetes (AOnAD).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabetes
Intervention
  • 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.
Study Groups/Cohorts
  • Adult Onset Autoimmune Diabetes/Latent Autoimmune Diabetes
    Interventions:
    • Other: Mixed Meal Test
    • Other: Dual Energy X-Ray Absorptiometry (DEXA)
    • Procedure: Adipose Tissue Biopsy
  • Type 2 Diabetes
    Interventions:
    • Other: Mixed Meal Test
    • Other: Dual Energy X-Ray Absorptiometry (DEXA)
    • Procedure: Adipose Tissue Biopsy
  • Type 1 Diabetes
    Interventions:
    • Other: Mixed Meal Test
    • Other: Dual Energy X-Ray Absorptiometry (DEXA)
    • Procedure: Adipose Tissue Biopsy
  • Healthy Normal Volunteers (HNV)
    Interventions:
    • Other: Mixed Meal Test
    • Other: Dual Energy X-Ray Absorptiometry (DEXA)
    • Procedure: Adipose Tissue Biopsy
Publications *
  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002. Review.
  • Rogers MAM, Kim C, Banerjee T, Lee JM. Fluctuations in the incidence of type 1 diabetes in the United States from 2001 to 2015: a longitudinal study. BMC Med. 2017 Nov 8;15(1):199. doi: 10.1186/s12916-017-0958-6.
  • Thomas NJ, Jones SE, Weedon MN, Shields BM, Oram RA, Hattersley AT. Frequency and phenotype of type 1 diabetes in the first six decades of life: a cross-sectional, genetically stratified survival analysis from UK Biobank. Lancet Diabetes Endocrinol. 2018 Feb;6(2):122-129. doi: 10.1016/S2213-8587(17)30362-5. Epub 2017 Nov 30.
  • Thunander M, Petersson C, Jonzon K, Fornander J, Ossiansson B, Torn C, Edvardsson S, Landin-Olsson M. Incidence of type 1 and type 2 diabetes in adults and children in Kronoberg, Sweden. Diabetes Res Clin Pract. 2008 Nov;82(2):247-55. doi: 10.1016/j.diabres.2008.07.022. Epub 2008 Sep 18.
  • Thomas NJ, Lynam AL, Hill AV, Weedon MN, Shields BM, Oram RA, McDonald TJ, Hattersley AT, Jones AG. Type 1 diabetes defined by severe insulin deficiency occurs after 30 years of age and is commonly treated as type 2 diabetes. Diabetologia. 2019 Jul;62(7):1167-1172. doi: 10.1007/s00125-019-4863-8. Epub 2019 Apr 10.
  • Turner R, Stratton I, Horton V, Manley S, Zimmet P, Mackay IR, Shattock M, Bottazzo GF, Holman R. UKPDS 25: autoantibodies to islet-cell cytoplasm and glutamic acid decarboxylase for prediction of insulin requirement in type 2 diabetes. UK Prospective Diabetes Study Group. Lancet. 1997 Nov 1;350(9087):1288-93. Erratum in: Lancet 1998 Jan 31;351(9099):376.
  • Barinas-Mitchell E, Kuller LH, Pietropaolo S, Zhang YJ, Henderson T, Pietropaolo M. The prevalence of the 65-kilodalton isoform of glutamic acid decarboxylase autoantibodies by glucose tolerance status in elderly patients from the cardiovascular health study. J Clin Endocrinol Metab. 2006 Aug;91(8):2871-7. Epub 2006 May 23.
  • Insel RA, Dunne JL, Atkinson MA, Chiang JL, Dabelea D, Gottlieb PA, Greenbaum CJ, Herold KC, Krischer JP, Lernmark Å, Ratner RE, Rewers MJ, Schatz DA, Skyler JS, Sosenko JM, Ziegler AG. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015 Oct;38(10):1964-74. doi: 10.2337/dc15-1419. Review.
  • Acevedo-Calado M, James EA, Morran MP, Pietropaolo SL, Ouyang Q, Arribas-Layton D, Songini M, Liguori M, Casu A, Auchus RJ, Huang S, Yu L, Michels A, Gianani R, Pietropaolo M. Identification of Unique Antigenic Determinants in the Amino Terminus of IA-2 (ICA512) in Childhood and Adult Autoimmune Diabetes: New Biomarker Development. Diabetes Care. 2017 Apr;40(4):561-568. doi: 10.2337/dc16-1527. Epub 2017 Feb 7.
  • Achenbach P, Hawa MI, Krause S, Lampasona V, Jerram ST, Williams AJK, Bonifacio E, Ziegler AG, Leslie RD; Action LADA consortium. Autoantibodies to N-terminally truncated GAD improve clinical phenotyping of individuals with adult-onset diabetes: Action LADA 12. Diabetologia. 2018 Jul;61(7):1644-1649. doi: 10.1007/s00125-018-4605-3. Epub 2018 Apr 4.
  • Brooks-Worrell BM, Boyko EJ, Palmer JP. Impact of islet autoimmunity on the progressive β-cell functional decline in type 2 diabetes. Diabetes Care. 2014 Dec;37(12):3286-93. doi: 10.2337/dc14-0961. Epub 2014 Sep 19.
  • Buzzetti R, Zampetti S, Maddaloni E. Adult-onset autoimmune diabetes: current knowledge and implications for management. Nat Rev Endocrinol. 2017 Nov;13(11):674-686. doi: 10.1038/nrendo.2017.99. Epub 2017 Sep 8. Review.
  • Hawa MI, Kolb H, Schloot N, Beyan H, Paschou SA, Buzzetti R, Mauricio D, De Leiva A, Yderstraede K, Beck-Neilsen H, Tuomilehto J, Sarti C, Thivolet C, Hadden D, Hunter S, Schernthaner G, Scherbaum WA, Williams R, Brophy S, Pozzilli P, Leslie RD; Action LADA consortium. Adult-onset autoimmune diabetes in Europe is prevalent with a broad clinical phenotype: Action LADA 7. Diabetes Care. 2013 Apr;36(4):908-13. doi: 10.2337/dc12-0931. Epub 2012 Dec 17. Erratum in: Diabetes Care. 2014 May;37(5):1494.
  • Mishra R, Hodge KM, Cousminer DL, Leslie RD, Grant SFA. A Global Perspective of Latent Autoimmune Diabetes in Adults. Trends Endocrinol Metab. 2018 Sep;29(9):638-650. doi: 10.1016/j.tem.2018.07.001. Epub 2018 Jul 23. Review.
  • Valadi H, Ekström K, Bossios A, Sjöstrand M, Lee JJ, Lötvall JO. Exosome-mediated transfer of mRNAs and microRNAs is a novel mechanism of genetic exchange between cells. Nat Cell Biol. 2007 Jun;9(6):654-9. Epub 2007 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2019) 		40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Recruitment Department 407-303-7100 fh.tri@flhosp.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03971955
Other Study ID Numbers 1437923
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Translational Research Institute for Metabolism and Diabetes, Florida
Study Sponsor Translational Research Institute for Metabolism and Diabetes, Florida
Collaborators Not Provided
Investigators
Principal Investigator: Anna Casu Study Principal Investigator
PRS Account Translational Research Institute for Metabolism and Diabetes, Florida
Verification Date June 2020

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