LONG TERM INVESTIGATIVE FOLLOW-UP IN TRIALNET (LIFT)(Protocol TN-16)

Study ID
STU 082012-050

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • CTRC Outpatient

Contact
Maria Pruneda
214-648-4717
maria.pruneda@utsouthwestern.edu

Principal Investigator
Philip Raskin

Summary

Subjects from natural History or Trialnet prevention studies:

Study visits for participants with detectable C-Peptide (at last available tolerance test result) will occur semi-annually.
Study visits for participants without detectable C-Peptide (at last available tolerance test result) will occur annually.

General assessments for semi-annual visits for this group (Group 1a):

* oral Glucose Tolerance Test (oGTT)
o Subjects will be requested to undergo up to 3 oGTT; a baseline test within 3 months of diagnosis, and at 6 months, and 12 months When available, C-peptide data from the oGTT determining their diagnosis will be considered the baseline test for this study. each oGTT will only be performed in subjects with detectable C-peptide on last available oGTT.

* Mixed Meal Tolerance Test (MMTT)
o To be performed on a separate day, if oGTT requested. each MMTT will only be performed in subjects with detectable C-peptide on last available MMTT. note: For subjects that undergo the oGTT at Baseline and 6 month visits; the MMTT will not be performed.

* Medical History
* Directed Physical exam
* Concomitant medications
* adverse event assessment
* Hemoglobin a1C
* Blood or urine tests as needed to follow-up on potential long term safety concerns with a particular therapeutic agent.
* Samples for mechanistic studies related to aim of this protocol as approved by Tn study committee

General assessments for annual visits for this group (Group 1B):
* Medical History
* Concomitant medications
* adverse event assessment
* Hemoglobin a1C
* Blood or urine tests as needed to follow-up on potential long term safety concerns with a particular therapeutic agent.
* Samples for mechanistic studies related to aim of this protocol as approved by Tn study committee

Subjects from all other Trialnet interventional studies:

Study visits for participants with detectable C-Peptide (at last available result) will occur semi-annually.

Study visits for participants without detectable C-Peptide (at last available result) will occur annually.

General assessments for semi-annual visits for this group (Group 2a):
* Mixed Meal Tolerance Test (MMTT)
* Medical History
* Directed Physical exam
* Concomitant medications
* adverse event assessment
* Hemoglobin a1C
* Blood or urine tests as needed to follow-up on potential long term safety concerns with a particular therapeutic agent
* Samples for mechanistic studies related to aim of this protocol as approved by Tn study committee

General assessments for annual visits for this group (Group 2B):
* Medical History
* Concomitant medications
* adverse event assessment
* Hemoglobin a1C
* Blood or urine tests as needed to follow-up on potential long term safety concerns with a particular therapeutic agent.
* Samples for mechanistic studies related to aim of this protocol as approved by Tn study committee

Visit Windows
* Semi-annual Visits: shall be performed within +/- 6 weeks of visit target date
* annual Visits: shall be performed within +/- 6 weeks of visit target date

Participant Eligibility

1. Type 1 diabetes
2. Prior participation in TrialNet study.
3. Willing to give, informed consent/assent (as applicable for children).