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Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133809
First Posted: August 24, 2005
Last Update Posted: July 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Nicole Turgeon MD, Emory University
  Purpose
This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness, or recurrent hyperglycemia with ketoacidosis.

Condition Intervention Phase
Diabetes Mellitus, Type 1 Drug: Transplantation of Human Islets Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Islet Transplantation in Type 1 Diabetes Using the Edmonton Protocol of Steroid Free Immunosuppression

Resource links provided by NLM:


Further study details as provided by Nicole Turgeon MD, Emory University:

Primary Outcome Measures:
  • The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation [ Time Frame: one year after transplant ]
    Independence from insulin injections is measured by the actual use of insulin by the study participants.


Secondary Outcome Measures:
  • Number of Insulin-independent Subjects Following Islet Transplantation [ Time Frame: 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation ]
    Participants who did not need to take insulin at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months following islet transplantation

  • Number of Subjects With HbA1C ≤ 6.5% [ Time Frame: 1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation ]
    HbA1C was assessed in subjects 1, 3, 6, 9,12,18,24, 36, 48 and 60 months after transplantation and the number of subjects with values ≤ 6.5% was recorded which indicated better control of blood glucose levels.

  • The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL [ Time Frame: 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation ]
    Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels at 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months after islet cell transplantation


Enrollment: 8
Study Start Date: July 2002
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Islet Transplant
All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant
Drug: Transplantation of Human Islets
Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus diagnosed > 5 years previously
  • Body mass index less than or equal to 26
  • 18 to 65 years of age
  • Compliance with an optimized diabetic management plan as assessed by an Emory University endocrinologist
  • Checking and recording blood sugars at least 3 times per day
  • Intensive insulin therapy (injecting insulin at least 3 times a day or using an insulin pump)
  • Severe hypoglycemia and/or hyperglycemia. Severe hypoglycemia is defined by: episodes requiring assistance by others and/or hypoglycemic unawareness (the inability to recognize blood glucose < 54 mg/dL). Severe hyperglycemia is defined by: two episodes of ketoacidosis requiring hospitalization within the past year.

Exclusion Criteria:

  • Renal dysfunction
  • Severe co-existing cardiac disease, characterized by any one of these conditions: recent myocardial infarction (within past six months); angiographic evidence of non-correctable coronary artery disease; or evidence of ischemia on a dobutamine stress echocardiogram.
  • Current bacterial or fungal infection
  • Macroproteinuria
  • Baseline hemoglobin < 11.4 gm/dL in women; < 12.9 gm/dL in men.
  • Hyperlipidemia
  • Positive tests for human immunodeficiency virus (HIV), or hepatitis B or C
  • Negative antibody test for varicella zoster virus (subjects may be reconsidered if they receive the vaccination and convert to a positive antibody)
  • History of malignancy (except squamous or basal cell skin carcinoma)
  • Previous/concurrent organ transplantation
  • Presence of HLA panel reactive antibodies > 20%
  • Active peptic ulcer disease
  • Evidence of gallbladder disease including cholecystitis and cholelithiasis
  • Evidence of liver disease including hepatic neoplasm, portal hypertension, or persistently abnormal liver function tests.
  • Persistent coagulopathy or current use of anticoagulants (not including aspirin)
  • Sickle cell anemia
  • Positive pregnancy test, intent for future pregnancy, failure to follow effective contraceptive measures, or presently breastfeeding
  • Active alcohol or substance abuse. This includes smoking (must be abstinent for six months). Active alcohol abuse should be considered using the current National Institute on Alcohol Abuse and Alcoholism (NIAAA) definitions.
  • Psychiatric disorder making the subject not a suitable candidate for transplantation
  • Current use of systemic steroid medications
  • Evidence of insulin resistance (insulin requirement > 1.2 units/kg/day)
  • Inability to provide informed consent
  • Any condition or any circumstance that makes it unsafe to undergo an islet transplant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133809


Locations
United States, Georgia
The Emory Transplant Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Nicole A Turgeon, MD Emory University
Principal Investigator: Christian P. Larsen, MD DPhil Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Nicole Turgeon MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00133809     History of Changes
Other Study ID Numbers: IRB00041120
10402 ( Other Identifier: Other )
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: April 25, 2016
Results First Posted: June 1, 2016
Last Update Posted: July 18, 2016
Last Verified: June 2016

Keywords provided by Nicole Turgeon MD, Emory University:
Type 1 Diabetes
Islet Transplantation
Immunology

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