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PET Scan Imaging of Beta Cell Mass

14. juli 2017 opdateret af: Columbia University

PET Scan Imaging of Pancreatic Beta Cell Mass With DTBZ

The investigators hypothesize that PET scans will be able to differentiate between normal, reduced or increased BCM in human subjects. Subjects with normal BCM will be recruited from among normal weight nondiabetic people with plasma insulin levels within the normal range. Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have with low or not measurable insulin levels. If results from the nondiabetic subjects and the subjects with T1DM are found to differ significantly, subjects with increased BCM will be recruited from among patients with hyperinsulinemia including those with obesity and the metabolic syndrome. PET scan measurements of the pancreas will be obtained and compared in people predicted, on the basis of biochemical testing, to have normal or reduced, or increased BCM.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

An important determinant of progression to diabetes is beta cell mass (BCM). Measurement of plasma insulin has been used as a surrogate marker but insulin levels often do not correlate well with beta cell mass and development of means to assess BCM would provide an important endpoint. For example, high-risk individuals could be monitored prior to onset of diabetes or patients could be monitored prospectively to determine the progression of their disease and response to therapy.

Both Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) develop when there is impaired insulin production. The amount of insulin that can be produced, the amount of insulin producing beta cells in the pancreas and level of insulin and glucose in the blood are, however, imperfectly correlated. The development of a reliable method to noninvasively quantitate the beta cell mass (BCM) would be of great benefit by providing an important endpoint for the development of new treatments of T1DM and T2DM. The investigators have previously identified a specific marker on islet cells called vesicular monoamine transporter 2 (VMAT2) that they now propose to use in positron emission tomography (PET) scanning to determine islet cell mass. This radioligand, [11C] Dihydrotetrabenazine (DTBZ), has been used previously in human subjects in clinical trials evaluating PET scanning of the brain in patients with bipolar illness and schizophrenia compared to healthy control subjects.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10032
        • Naomi Berrie Diabetes Cener
      • New York, New York, Forenede Stater, 19932
        • Kreitchman PET Center Columbia University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Potential subjects with diabetes will be recruited from among the patients cared for at the Naomi Berrie Diabetes Center. Nondiabetic subjects will either be referred by their physicians or by word of mouth. Primary care physicians will be made aware of the study by fliers.

Beskrivelse

Inclusion Criteria:

Potential participants must meet all of the following inclusion criteria:

  1. Informed consent obtained from participants
  2. Age 18-45 years
  3. Healthy non-diabetic subjects will have normal fasting blood sugar (<100 mg/dl), body mass index (BMI) 18.5-24.9, no history of type 2 diabetes in first degree relative
  4. Type 1 diabetes defined by: American Diabetes Association (ADA) criteria or judgment of physician; diabetes onset younger than age 18, duration >5 - years, BMI 18.5-24.9. Insulin dose <0.8 units/kg/day. Fasting c-peptide < 0.1 ng/ml
  5. Obese hyper-insulinemic subjects will have BMI > 30 and fasting insulin>20 and c-peptide> 4.6 ng/ml and normal fasting blood sugar <100 mg/dl.
  6. Able to tolerate PET imaging: not claustrophobic, able to lie supine for 1.5 hours
  7. Normal liver and renal function tests including normal spot urine microalbumin /creatinine; normal CBC including hematocrit >31.8% in women, >36.7% in men, white blood cell (WBC) count >3.4 K/mm3 and platelet count >162 K/mm3
  8. Adequate collateral circulation in the wrist as assessed by Allen Test.

Exclusion Criteria:

Potential participants must not have any of the following exclusion criteria:

  1. Previous or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. oral hypoglycemic agents, glucocorticoids); or with antipsychotic, antianxiety, or antidepressant medications (eg monoamine oxidase (MAO) inhibitors, 5-hydroxytryptamine (5-HT) inhibitors, tricyclic antidepressants); or treatment with reserpine; or treatment with beta2receptor agonists (eg, terbutaline); or treatment with anticoagulant medication.
  2. History of movement disorder such as Parkinson's Disease or Huntington's Disease
  3. History of or psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia.
  4. If a female of childbearing age, currently pregnant, breastfeeding or not using a form of birth control
  5. Previous or current use of cocaine, methamphetamine, ecstasy
  6. Current daily intake of caffeine >500 mg/day (>45 cups of coffee; >10 12oz cans of soda)
  7. Current history of cigarette smoking
  8. Consumption of more than 1 alcoholic drink per day
  9. Evidence of chronic infection
  10. History of malignancy
  11. Any prior participation in other research protocols within the past year that involve radiation, with the exception of plain radiography studies (i.e., chest xrays).
  12. Medical implant

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
A. Healthy Controls
subjects w/ predicted normal BCM (healthy, normalweight, nondiabetic individuals who have stimulated insulin and cpeptide levels within the normal range);
B. Longstanding T1D
subjects with predicted reduced beta cell mass (subjects with established T1DM who have low or not measurable stimulated insulin and c peptide levels);
C. Obese Subjects
subjects with predicted increased beta cell mass (euglycemic obese subjects with fasting hyperinsulinemia).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pancreas [11C] DTBZ binding
Tidsramme: Once
Once

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Columbia University

Efterforskere

  • Studieleder: PAUL E HARRIS, Ph.D., Columbia University
  • Ledende efterforsker: Robin S Goland, M.D., Columbia University
  • Ledende efterforsker: Ronald Van Heertum, M.D., Columbia University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2006

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

13. juni 2012

Datoer for studieregistrering

Først indsendt

10. oktober 2008

Først indsendt, der opfyldte QC-kriterier

10. oktober 2008

Først opslået (Skøn)

13. oktober 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AAAB0002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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