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Data from Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation (CIT-01) [(Version 1) https://doi.org/10.58020/v6zz-1r31] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
The CIT-01 study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the CIT-01 (https://doi.org/10.58020/v6zz-1r31) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the CIT-01 study and does not necessarily reflect the opinions or views of the CIT-01 study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: May 13, 2019)
Resource Availability
- Data Available for Request
- Specimens Not Available
General Description
The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. CIT01 participants were randomized to study treatment including Low Molecular Weight Sulfated Dextran (LMW-DS) and study treatment without LMW-DS. Subjects in both arms received induction and maintenance immunosuppression consisting of ATG (basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus, and tacrolimus. CIT01 subjects randomized to the LMW-DS arm also received LMW-DS before and during islet transplant.
Objectives
The primary objective is to evaluate the safety and efficacy of Low Molecular Weight Dextran Sulfate (LMW-DS) to enhance engraftment and prevent IBMIR in islet transplantation to Type 1 diabetic subjects. The secondary objective is to gather additional safety and efficacy information about the combination of Low Molecular Weight Sulfated Dextran with islet transplantation.
Outcome Measure
The level of stimulated c-peptide at 90-minutes derived from the mixed-meal tolerance test (MMTT) at 75+/-5 days following the first islet infusion.
Outcome
This study has ended.
Research Area
Diabetes
Study Type
Interventional
Study Start Date
2008-07
Study End Date
2014-08
Condition
Type 1 Diabetes Mellitus
Clinical Trials URL
Study Website
Keywords
Islet Cell Transplantation, Basiliximab, Etanercept, Low Molecular Weight Sulfated Dextran (LMW-SD), Tacrolimus, Diabetes Mellitus, Type 1, Sirolimus
NIDDK Division
Division of Diabetes, Endocrinology, and Metabolic Diseases
24
Participants
Target Population
Transplant Patients, Adults
Document Name | Description | Document Type | File Format | Compliance | Download |
|---|---|---|---|---|---|
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov
Permitted Use(s) of the Resources
- Use is allowed for any research purpose
Non-Public Documents (4)
Document Name | Description | Document Type | File Format |
|---|---|---|---|
Datasets (66)
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
|---|---|---|---|---|
LDH Dataset | Captures data Lactate Dehydrogenase (LDH) levels | 492 | sas7bdat (128 KB); csv (12.69 KB) | |
Clarke Dataset | Captures data related to low blood sugar status and symptoms, including confusion, seizures, unconsciousness, and requiring intravenous glucose or glucagon | 134 | sas7bdat (128 KB); csv (8.26 KB) | |
Eosinophils Dataset | Captures data on eosinophil cell levels | 471 | sas7bdat (128 KB); csv (11.72 KB) | |
Pilot Endpoints Dataset | Captures data on primary endpoint criteria, information, and results | 24 | sas7bdat (128 KB); csv (1.08 KB) | |
Diastolic Blood Pressure | Captures diastolic blood pressure, number of days from initial transplant, and time point indicator based on initial and final transplant | 473 | sas7bdat (128 KB); csv (14.02 KB) | |
Albumin Dataset | Captures albumin test results, units, and number of days from initial transplant | 474 | sas7bdat (128 KB); csv (12.35 KB) | |
Sodium Dataset | Captures sodium laboratory value and time point indicator based on initial and final transplant | 497 | sas7bdat (128 KB); csv (13.42 KB) | |
Local LDL Dataset | Captures data on local LDL laboratory value, unit, and time point indicator based on initial and final transplant | 332 | sas7bdat (128 KB); csv (11.26 KB) | |
Local Total Cholesterol Dataset | Captures data on local total cholesterol laboratory value and time point indicator based on initial and final transplant | 347 | sas7bdat (128 KB); csv (11.97 KB) | |
Lability Index (LI) Score Dataset | Captures Lability Index (LI) Score and time point indicator based on initial and final transplant | 93 | sas7bdat (128 KB); csv (2.45 KB) | |
Hematocrit Dataset | Captures data on hematocrit laboratory value, unit, and time point indicator based on initial and final transplant | 497 | sas7bdat (128 KB); csv (12.94 KB) | |
Potassium Dataset | Captures potassium laboratory value, unit, and time point indicator based on initial and final transplant | 498 | sas7bdat (128 KB); csv (13.33 KB) | |
General Assessment Dataset | Captures general assessment data, including tuberculosis results, ECG interpretation, stress test interpretation, X-ray results, urinalysis results, abdominal ultrasound interpretation, and myocardial scintigram interpretation | 204 | sas7bdat (128 KB); csv (16.06 KB) | |
Patient Status Dataset | Captures patient status data, including number of transplants and number of days since first transplant | 24 | sas7bdat (128 KB); csv (629 B) | |
Endpoints Dataset | Captures data on all endpoint information and test results | 144 | sas7bdat (128 KB); csv (10.3 KB) | |
Systolic Blood Pressure Dataset | Captures systolic blood pressure (mm HG) and time point indicator based on initial and final transplant | 473 | sas7bdat (128 KB); csv (14.46 KB) | |
Blood Type HLA Dataset | Captures data on blood type and HLA | 26 | sas7bdat (128 KB); csv (1.33 KB) | |
Beta Score Dataset | Captures data on fasting glucose score, HbA1c score, insulin score, stimulated Cpeptide at 90 minutes score, beta score (sum of glucscore, hba1score, insulin score, and cpepscore) and time point indicator based on initial and final transplant | 97 | sas7bdat (128 KB); csv (2.98 KB) | |
Fibrinogen Dataset | Captures data on fibrinogen levels | 474 | sas7bdat (128 KB); csv (11.86 KB) | |
AST Dataset | Captures AST test results, time point indicator based on initial and final transplant, and number of days from initial transplant | 498 | sas7bdat (128 KB); csv (15.37 KB) | |
APTT Dataset | Captures data on Activated Partial Thromboplastin Time (APTT) test results | 477 | sas7bdat (128 KB); csv (11.45 KB) | |
Lymphocyte Dataset | Captures data on lymphocytes laboratory value and time point indicator based on initial and final transplant | 471 | sas7bdat (128 KB); csv (14.42 KB) | |
Neutrophils Dataset | Captures neutrophil laboratory value and time point indicator based on initial and final transplant | 472 | sas7bdat (128 KB); csv (14.4 KB) | |
Local HDL Dataset | Captures data on local HDL laboratory value, unit, and time point indicator based on initial and final transplant | 333 | sas7bdat (128 KB); csv (11.18 KB) | |
Blood Sugar Dataset | Captures blood sugar reading measurement (mg/DL), meal time indicator, autonomic, confusion, neurologic, seizure, and visual hypoglycemia symptoms, and treatment for reaction | 40052 | sas7bdat (5.94 MB); csv (2.29 MB) | |
Monocytes Dataset | Captures data on monocyte levels | 471 | sas7bdat (128 KB); csv (11.77 KB) | |
RBC Count Dataset | Captures data on red blood cell count | 488 | sas7bdat (128 KB); csv (11.27 KB) | |
Alkaline Phosphatase Dataset | Captures alkaline phosphatase test results, units, and number of days from initial transplant | 494 | sas7bdat (128 KB); csv (13.08 KB) | |
DTSQc Dataset | Captures data on Diabetes Treatment Satisfaction Questionnaire (DTSQ) results | 30 | sas7bdat (128 KB); csv (1.47 KB) | |
Safety Dataset | Captures data on safety and adverse events, including system organ class, severity, and relation to islet, immunosuppression, or drug | 268 | sas7bdat (128 KB); csv (22.88 KB) | |
Local Serum Creatinine Dataset | Captures data on local serum creatinine laboratory value, unit, and time point indicator based on initial and final transplant | 498 | sas7bdat (128 KB); csv (13.87 KB) | |
Local Triglycerides Dataset | Captures data on local triglycerides cholesterol laboratory value and time point indicator based on initial and final transplant | 344 | sas7bdat (128 KB); csv (12.39 KB) | |
MAGE Score Dataset | Captures data on mean amplitude of glycemic excursions (MAGE) (mg/dL) and time point indicator based on initial and final transplant | 108 | sas7bdat (128 KB); csv (2.67 KB) | |
Hypoglycemic Score Dataset | Captures data on composite hypoglycemic score and time point indicator based on initial and final transplant | 93 | sas7bdat (128 KB); csv (2.18 KB) | |
FSIGT AIRglu Dataset | Captures data on acute insulin response to glucose (AIRglu) derived from FSIGT and time point indicator based on initial and final transplant | 73 | sas7bdat (128 KB); csv (2.83 KB) | |
Hypoglycemic Recall Dataset | Captures recall data related to hypoglycemia, including number of hypoglycemic episodes in the past year the subject needed help to recognize, help to treat, or required an ambulance call | 112 | sas7bdat (128 KB); csv (3.54 KB) | |
Auto Antibodies Dataset | Captures data on positive baseline IAA, positive baseline GAD65, and positive baseline ICA512 | 135 | sas7bdat (128 KB); csv (5.16 KB) | |
Pulse Dataset | Captures pulse (beats/min) data and time point indicator based on initial and final transplant | 471 | sas7bdat (128 KB); csv (13.96 KB) | |
Serology Dataset | Captures serology data including viruses such as HIV, hepatitis C, Epstein-Barr, cytomegalovirus, etc. | 158 | sas7bdat (128 KB); csv (8.88 KB) | |
PK Dataset | Captures data on pyruvate kinase (PK) levels | 478 | sas7bdat (128 KB); csv (11.56 KB) | |
Bilirubin Dataset | Captures data on bilirubin laboratory value, unit, and number of days from initial transplant | 495 | sas7bdat (128 KB); csv (12.55 KB) | |
Insulin Dataset | Captures data on insulin use (units/day) and time point indicator based on initial and final transplant | 5671 | sas7bdat (384 KB); csv (175.92 KB) | |
Conduction Velocity Dataset | Captures data on conduction velocity results related to the participant's neurology | 57 | sas7bdat (128 KB); csv (7.18 KB) | |
CGMS Dataset | Captures data on glucose average sensor value, number of episodes, duration, etc. | 104 | sas7bdat (128 KB); csv (17.54 KB) | |
WHO Coding Dataset | Captures data on Anatomical Therapeutic Chemical Classification (ATC) code and coded drug name | 526 | sas7bdat (128 KB); csv (30.38 KB) | |
Urine Albumin Dataset | Captures data on urine albumin levels | 106 | sas7bdat (128 KB); csv (2.55 KB) | |
CRP Dataset | Captures data on C-Reactive Protein (CRP) measurements | 495 | sas7bdat (128 KB); csv (12.47 KB) | |
Hemoglobin Dataset | Captures data on hemoglobin laboratory value, unit, and time point indicator based on initial and final transplant | 499 | sas7bdat (128 KB); csv (15.66 KB) | |
DTSQs Dataset | Captures data on Diabetes Treatment Satisfaction Questionnaire (DTSQ) results | 86 | sas7bdat (128 KB); csv (3.88 KB) | |
Basophils Dataset | Captures data on basophil cell levels | 471 | sas7bdat (128 KB); csv (11.45 KB) | |
White Blood Count Dataset | Captures white blood count laboratory value and time point indicator based on initial and final transplant | 498 | sas7bdat (128 KB); csv (15.17 KB) | |
SF-36 Dataset | Captures patient-reported data on quality of life and well-being from the SF-36 Health Survey | 145 | sas7bdat (128 KB); csv (16.32 KB) | |
Cpeptide Glucose Creatinine Dataset | Captures data on graft function, fasting and stimulated Cpeptide, fasting and stimulated glucose, and creatinine ratio | 114 | sas7bdat (128 KB); csv (8.79 KB) | |
FSIGT Raw Dataset | Captures data on glucose (mg/dL), insulin (Tosoh) (uU/mL), and time point indicator based on initial and final transplant | 1730 | sas7bdat (192 KB); csv (61 KB) | |
HbA1c Dataset | Captures data on HbA1c derived from the Washington lab and time point indicator based on initial and final transplant | 266 | sas7bdat (128 KB); csv (8.21 KB) | |
Platelets Dataset | Captures platelets laboratory value and time point indicator based on initial and final transplant | 490 | sas7bdat (128 KB); csv (15.14 KB) | |
Rudbeck Clinical Dataset | Captures data on Cpeptide (pmol/L), C3a (ug/L), and TAT III complex (ug/L) | 234 | sas7bdat (128 KB); csv (10.22 KB) | |
Mean Insulin Dataset | Captures mean insulin (units/day) over a 7 consecutive day interval (7 closest days prior to transplant for baseline), weight, and time point indicator based on initial and final transplant | 84 | sas7bdat (128 KB); csv (4.85 KB) | |
PRA Dataset | Captures data on percent calculated PRA and number of days from initial transplant | 249 | sas7bdat (128 KB); csv (5.23 KB) | |
Planned Visit Dictionary Dataset | Captures data from CIT 01 planned visit dictionary | 18 | sas7bdat (128 KB); csv (1.34 KB) | |
Drugs Dataset | Captures data on randomization drug given to each participant | 24 | sas7bdat (128 KB); csv (646 B) | |
ALT Dataset | Captures ALT test results, time point indicator based on initial and final transplant, and number of days from initial transplant | 498 | sas7bdat (128 KB); csv (15.37 KB) | |
Glomerular Filtration Rate Dataset | Captures glomerular filtration rate, unit, and time point indicator based on initial and final transplant | 80 | sas7bdat (128 KB); csv (2.81 KB) | |
Demographics Dataset | Captures demographic data including gender, age at first transplant, race; also captures data on duration of diabetes, weight, and BMI | 24 | sas7bdat (128 KB); csv (1.19 KB) | |
Medical History Dataset | Captures medical history data including allergies, hospitalizations, and any conditions | 24 | sas7bdat (128 KB); csv (1.39 KB) | |
Weight Dataset | Captures weight (kg) data and time point indicator based on initial and final transplant | 312 | sas7bdat (128 KB); csv (9.66 KB) |