Long Term Follow up of Recipients of Functional Islet Allografts

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier:
NCT01999374
First received: November 25, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

Since its inception, the Diabetes Research Institute (DRI) has made significant contributions to the field of diabetes, pioneering many of the techniques used in diabetes centers around the world. Through several clinical trials, DRI has demonstrated that diabetes can be successfully reversed as a result of islet cell transplant.

Over the years the following protocols in islet cell transplantation have been initiated: 2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.

All of the studies listed above will be source of study subjects for this study. Approximately 30 subjects are expected to be enrolled and followed in this trial.

After islet-cell transplantation in the parent studies, each subject receives maintenance immunosuppressive medications.

The purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their parent study.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Long Term Follow up of Recipients of Functional Islet Allografts

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Duration of sustained islet allograft function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The primary endpoint is duration of sustained islet allograft function as determined by evidence from Mixed Meal Tolerance Test of c-peptide production. A c-peptide level >=0.3 ng/ml at 0, 60, or 90 minutes will be considered evidence of islet allograft function.


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Detailed Description:

To provide long term follow up in subjects with functional islet allografts.

  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

Subject with Type 1 diabetes mellitos status post islet transplantation

Criteria

Inclusion Criteria:

  1. Participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210
  2. A functioning pancreatic islet graft (absence of graft failure as defined in parent study) requiring immunosuppression.
  3. Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.
  4. Ability to provide written informed consent.

Exclusion Criteria:

  1. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
  2. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999374

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
Investigators
Principal Investigator: Rodolfo Alejandro, MD University of Miami
  More Information

Additional Information:
No publications provided

Responsible Party: Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT01999374     History of Changes
Other Study ID Numbers: 20130034
Study First Received: November 25, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

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 August 28, 2014