Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation

This study is currently recruiting participants.
Verified December 2013 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier:
NCT02004964
First received: November 25, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

Protocol to screen potential subjects for islet transplantation


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • eligibility for islet transplantation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This trial has the objective to determine subject eligibility for future islet transplant trials using fasting labs (including CBC, Chemistry, PRA, auto-antibodies, coagulation panel and others); a mixed meal tolerance test, psychological evaluation and a physical exam.


Estimated Enrollment: 600
Study Start Date: April 2009
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with type 1 DM

Criteria

Inclusion Criteria:

  1. Patients between 18 and 65 years of age
  2. Patients with type 1 diabetes mellitus for more than 5 years duration
  3. Body Mass Index (BMI) 4. Fulfill one or more of the following:

1. Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms include hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness, (the inability to recognize low blood glucoses; glucoses <54 mg/dl). These patients are at high risk for involvement in accidents (they can lose consciousness or act irrationally), thus causing harm to themselves and/or others; and/or 2. Patients with poor diabetes control (HbA1c > 8.0% but < 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, and multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an Endocrinologist. These patients can experience acute, rapid hyperglycemia secondary to several stress factors, that can lead to dehydration, disorientation, and in some instances, ketoacidosis; and/or 3. Progressive diabetic complications. These patients with chronically poor glycemic control are at higher risk for the development of a wide variety of complications (retinopathy, neuropathy, nephropathy, and cardiovascular disease) associated with diabetes.

Exclusion Criteria:

Potential candidates will be excluded as per following criteria:

  1. Age <18 or >65 years;
  2. Duration of diabetes <5 years;
  3. Do not have a physician that is monitoring diabetes for > 6 months;
  4. Body Mass Index >30
  5. Weight >80 kg;
  6. Insulin requirement >1.0 u/kg/d;
  7. HbA1C >12%;
  8. Stimulated or basal C-peptide >0.3 ng/ml;
  9. Iohexol GFR<80
  10. Macroalbuminuria (>300 mg/24 hours);
  11. Anemia consistently lower than the normal range.
  12. Hyperlipidemia (fasting LDL cholesterol>130mg/dl and/or fasting triglycerides >200mg/dl);
  13. Abnormal liver function tests (consistently >1.5 x normal range);
  14. Serological evidence of HIV, HBsAg and/or HBcAb, HBsAb without history of vaccination, HTLV-1 or HCV;
  15. Negative serology for Epstein Barr virus (EBV) or evidence of acute or chronic infection (IgM≥IgG);
  16. Lack of updated immunizations per current CDC guidelines (including Lack of immunization against hepatitis B, pneumococcus and influenza - during season);
  17. Presence of panel reactive antibodies by flow cytometry
  18. Prostate specific antigen (PSA) >4 ng/ml unless malignancy ruled out;
  19. Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided);
  20. X-ray evidence of pulmonary infection or other significant pathology;
  21. Gall stones and/or portal hypertension and/or hemangioma on liver ultrasound;
  22. Abnormal abdominal or pelvic ultrasound (evidence of masses that are considered suspicious for malignancy or adenopathy);
  23. Active peptic ulcer disease;
  24. Active infections;
  25. Unstable cardiovascular status (including positive stress echocardiography if >age 35)/MI in the past 6 months/LVEF<30%)
  26. Untreated or unstable proliferative diabetic retinopathy;
  27. Previous/concurrent organ transplantation (except failed islet cell or pancreas transplantation);
  28. Malignancy or previous malignancy;
  29. Any medical condition requiring chronic use of steroids;
  30. Active alcohol or substance abuse; smoking in the last 6 months;
  31. Sexually active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable; condoms used alone are not acceptable);
  32. Positive pregnancy test or intent for future pregnancy, or male subject's intent to procreate;
  33. Any condition or any circumstances that makes it unsafe to undergo an islet cell transplant;
  34. Psychogenically unable to comply;
  35. Failed psychological evaluation.
  36. Persistent leukopenia (white blood cell count <3,000/uL on more than 3 occasions)
  37. Acute or chronic pancreatitis.
  38. Severe or unremitting diarrhea, vomiting or othe gastrointestinal disorder potentially interfering with the ability to absorb oral medications.
  39. Lymphopenia - < 1,000/uL 40 Neutropenia - <1,500/uL

41. Thrombocytopenia - <100,000/uL

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004964

Locations
United States, Florida
Diabetes Research Institute Recruiting
Miami, Florida, United States, 33136
Contact: Rodolfo Alejandro, MD    305-243-5321    islet@med.miami.edu   
Principal Investigator: Rodolfo Alejandro, MD         
Sponsors and Collaborators
Rodolfo Alejandro
  More Information

Additional Information:
No publications provided

Responsible Party: Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02004964     History of Changes
Other Study ID Numbers: 20053135
Study First Received: November 25, 2013
Last Updated: December 3, 2013
Health Authority: Unites States: UM - Medical Sciences IRB A

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014