- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073070
RBC Lifespan Measurement in Diabetic Children
Red Blood Cell Lifespan Measurement in Diabetic Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening visit: There will be one screening visit before the study. We will do some blood tests that will determine if the subjects can be in this study. If the subject is qualify, he/she will be asked to return for the following scheduled visits.
Study visit 1: We will draw a small amount of subject's blood from the IV. The study subject's blood will then be marked with biotin. We will give back the subject's blood marked with biotin through IV within 4 to 6 hours. Endotoxin analysis (conducted pre-infusion) and bacterial culture analysis (conducted post-infusion) will be performed. Twenty minutes after the blood transfusion, we will draw blood from the IV. After that, we will take out the IV and the subject can go home.
All follow-up study visits:
The subject will have a study visit 24 hours after receiving blood marked with biotin. After that, the subject will have a clinic visit every 7-10 days. These visits will end when we can no longer find the biotin marked blood cells in the subject's blood. This is expected to be approximately 12 weeks later.
At these visits, we will draw blood and also collect all blood glucose results in the past 7-10 days.
After the study visits are completed, there will be one follow-up visit 4-6 months after the subject receives the biotin marked RBCs. We will draw about 0.25 ml of blood.
Continuous glucose monitoring and HbA1c determination-- We will monitor continuous glucose concentrations throughout the study. This will be accomplished by setting up FreeStyle Libre Pro continuous glucose monitoring (CGM) device for each study subject. In addition, HbA1c will be measured once in the middle of the study (likely visit 6) and in the end of the study (likely visit 12).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children with either type1 or type 2 diabetes between 4-18 years old
Exclusion Criteria:
- consumption of biotin supplements or raw eggs within 30 days;
- history of gastrointestinal blood loss;
- heart failure ;
- active viral or bacterial infection;
- hemoglobinopathy;
- prior history of liver disease with transaminases more than 3 times the upper limit of normal for age;
- uncontrolled thyroid disease;
- anemia (whole blood HCT<33);
- history of renal disease (prior serum creatinine more than >1.5 mg/dlL);
- detectable antibody to biotin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biotin labeled RBCs in 4-10 year old diabetes children
Biotin labeled autologous RBCs will be transfused to the subjects
|
Autologous red blood cells are biotin labeled and transfused to the subjects.
Survival of these red blood cells is tracked through examination of blood samples until no biotin-labeled red blood cells is detectable.
Other Names:
|
Experimental: Biotin labeled RBCs in 10-18 year old diabetes children
Biotin labeled autologous red blood cells will be transfused to the subjects
|
Autologous red blood cells are biotin labeled and transfused to the subjects.
Survival of these red blood cells is tracked through examination of blood samples until no biotin-labeled red blood cells is detectable.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of RBC survival in diabetic children using biotin-labeled RBCs
Time Frame: 50 days to 120 days
|
the lifespan of red blood cells in children with diabetes
|
50 days to 120 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guohua An, MD, PhD, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201612763
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on biotin labeled RBCs
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
John A WidnessNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
John A WidnessNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsCompleted
-
VA Office of Research and DevelopmentUniversity of CincinnatiTerminatedDiabetes Mellitus | Prediabetes | Impaired Fasting GlucoseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)Children's National Research InstituteRecruitingSickle Cell Disease | Thalassemia | HemoglobinopathyUnited States
-
Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI)Terminated
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI); Cerus CorporationRecruiting
-
Cerus CorporationCompletedFocus: Assess Post Infusion Viability of S303 RBCsUnited States
-
Cerus CorporationCompletedFocus:Use of S303 RBCs in Patients With Acute AnemiaGermany
-
New York Blood CenterWestchester Medical CenterWithdrawnAnemia | Transfusion ReactionUnited States