Recruiting

Observational Study

Sponsor:

Rodolfo Alejandro

Code:

NCT02000687

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT02000687

Start date

Dec, 2008

Status verified date

Mar, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1\. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).

Exclusion Criteria:

1. Inability to provide written informed consent.
2. Mentally unstable and/or unable to comply with the procedures of the study protocol.
3. History of any solid organ transplant.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • determine the rate of allosensitization in patients after failed islet transplantation [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

Diabetes Research Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Rodolfo Alejandro, MD

305-243-5321islet@med.miami.edu

Ana M Alvarez, APRN

305 243-3389axa383@med.miami.edu

Principal Investigator:

Rodolfo Alejandro, MD

More Information

Sponsor

Rodolfo Alejandro

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rodolfo Alejandro on 2026-03-23.