Status:
COMPLETED
Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
Type 1 diabetes mellitus (T1DM) develops when there is impaired insulin production due to loss of insulin producing cells (beta cells). The amount of insulin that can be produced is imperfectly correl...
Detailed Description
Diabetes results when the insulin secretory capacity of the beta cell population is lost or severely compromised.Plasma insulin levels have been used as a surrogate marker of beta cell mass (BCM) but ...
Eligibility Criteria
Inclusion
- Patients with type 1 diabetes may be enrolled if they meet all of the following criteria:
- Are males or females between 18 and 70 years of age, inclusive
- Have a diagnosis of type 1 diabetes mellitus as defined by the American Diabetes Association (ADA) criteria or by diagnosed as per their endocrinologist; duration \>5 years; Insulin dose requirements \<0.8 units/kg/day
- HbA1c level between 5% and 8.5%
- Have fasting C-Peptide \< 0.1 ng/ml
- Have a body mass index (BMI) between 18 and 32 kg/m2
- Able to tolerate PET imaging
- In the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and Day 1 imaging procedures
- Give informed consent
- Healthy volunteers may be enrolled if they meeting all of the following criteria:
- Are males or females between 18 and 70 years of age, inclusive
- Have no history of type 1 or type 2 diabetes in a first degree relative
- Fasting blood glucose less than 100 mg/dL
- HbA1c level less than 6%
- Normal Mixed Meal Tolerance test at screening visit
- BMI between 18 and 32 kg/m2
- Able to tolerate PET imaging
- In the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and Day 1 imaging procedures, and
- Give informed consent
Exclusion
- Potential participants must not have any of the following exclusion criteria:
- Clinically significant renal dysfunction
- Clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (aspartate aminotransferase (AST), alanine aminotransferase (ALT), Total/Direct Bilirubin, Alkaline Phosphatase)
- Coagulopathy
- Use medications known to affect dopaminergic function, including monoamine oxidase (MAO) inhibitors, tetrabenazine, or levodopa
- Recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine) medications known to affect dopaminergic function, including MAO inhibitors, tetrabenazine, or levodopa
- Have polycystic ovarian syndrome
- History of movement disorder such as Parkinson's Disease, Huntington's Disease
- Clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia
- Current use (within past year) of cocaine, methamphetamine, and/or ecstasy (3,4methylenedioxymethamphetamine (MDMA))
- Have a recent history of alcohol or substance abuse or dependence
- Clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (ECG) (including but not limited to QT-interval time corrected \> 450 msec)
- Clinically significant pulmonary, renal or hepatic impairment, or cancer
- Have clinically significant infectious disease, including acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection or previous positive test for hepatitis B, hepatitis C, or HIV.
- Are women of childbearing potential not refraining from sexual activity or not using adequate contraception.
- Women must not be pregnant (negative serum human chorionic gonadotropin (hCG) at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant during for 30 days following the clinical trial
- Require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
- Weigh more than the manufacturer recommended limit for the PET/computed tomography (CT) camera being used
- Any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); And
- Have received a diagnostic or therapeutic radiopharmaceutical within the past week
Key Trial Info
Start Date :
July 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02236754
Start Date
July 2 2013
End Date
April 23 2014
Last Update
July 23 2024
Active Locations (1)
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1
Naomi Berrie Diabetes Center
New York, New York, United States, 10032