type1diabetes Clinical Trial
Official title:
Assessment of Pancreatic Beta Cell Mass and Function With the Aid of Positron Emission Tomography Imaging in Human Diabetes Mellitus
NCT number | NCT05662189 |
Other study ID # | 462 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2022 |
Est. completion date | December 2024 |
The goals of this project are to build an experimental tool to dissect out in vivo pancreatic beta cell mass (BCM) and beta cell function (BCF) and to assess for the first time these two determinants of beta cell functional mass (BCFxM) in obesity and in various stages of type 1 and type 2 diabetes mellitus.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age =18 years; = 75 years - Both sexes - Good health - Absence of exclusion criteria - Able to understand methods, goals, and implications of the research and of delivering a free, written informed consent Exclusion Criteria: - Hemoglobin < 12 g/dl - HbA1c > 10% - Pregnancy or breast-feeding - If not in menopause, women not using effective birth control methods or not willing to undergo a pregnancy test - History of severe psychiatric disorder or alcohol abuse - Recent head traumas (<6 months) - Active neurologic diseases - Claustrophobia - Active malignant neoplasms - Severe kidney and/or liver disease - Recent (<6 months) major adverse cardiovascular events - Heart failure (class NYHA 3-4) - Drugs known to affect beta cell function and/or insulin sensitivity - Current or past treatment with GLP1R-agonists - Intolerance to exenatide - Endocrine diseases, other than diabetes mellitus, known to affect beta cell function and/or insulin sensitivity, except well controlled hypothyroidism or adrenal insufficiency - COPD on day time oxygen therapy - Any current acute disease |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria di Parma | Parma | Pr |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Parma | University of Parma |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BCF x M | BCFxM=parameters derived from mixed meal test
Beta cell function(BCF)=BCFxM/BCM |
through study completion, an average of 3 months after enrolment | |
Primary | pancreatic beta cell mass (BCM) | Beta cell mass index (BCM) = 68GA-exendin-4 Standard Uptake Value (SUV)*pancreatic volume | through study completion, an average of 3 months after enrolment | |
Primary | pancreatic beta cell function (BCF) | BCFxM/BCM | through study completion, an average of 3 months after enrolment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03886974 -
Transition to Adult Care in Type 1 Diabetes
|
||
Completed |
NCT05620251 -
Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
|
||
Completed |
NCT03623113 -
The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05078658 -
Low-carbohydrate Diet in Children With Type 1 Diabetes
|
N/A | |
Not yet recruiting |
NCT06018324 -
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
|
||
Withdrawn |
NCT03736083 -
Introducing CGM at Type 1 Diabetes Diagnosis
|
N/A | |
Completed |
NCT03177096 -
Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes
|
N/A | |
Not yet recruiting |
NCT06418269 -
The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes
|
N/A | |
Completed |
NCT04172077 -
Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
|
||
Recruiting |
NCT04950634 -
Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
|
||
Completed |
NCT04450745 -
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
|
N/A | |
Completed |
NCT03165786 -
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
|
N/A | |
Terminated |
NCT04028960 -
IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase
|
Phase 2 | |
Recruiting |
NCT05324488 -
Diabetes Registry Graz for Biomarker Research
|
||
Completed |
NCT02984709 -
Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes
|
N/A | |
Completed |
NCT02984514 -
Brown Adipose Tissue in Type 1 Diabetes
|
N/A | |
Recruiting |
NCT06372392 -
Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps
|
N/A | |
Recruiting |
NCT03311516 -
New Insulin Therapy by Multiwave Bolus
|
N/A | |
Recruiting |
NCT05973799 -
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
|
N/A | |
Completed |
NCT03711656 -
Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques
|
N/A |