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Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant

NCT03415139 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-03-28

No results posted yet for this study

Summary

This clinical research studies the physiology and immunology of new-onset post-transplant diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose tolerance tests (OGTT), hyperglycemic clamps, and immune assays will be used to define the mechanisms associated with abnormal glucose homeostasis following stem cell transplantation. Information from this clinical trial could be used to develop standardized screening procedures or to develop optimal treatment strategies for patients developing post-transplant diabetes mellitus.

Conditions

Interventions

DRUG

Oral Glucose Tolerance Test (OGTT)

A standard OGTT will be performed. During OGTT 75gm of glucose will be given followed by phlebotomy.

DRUG

2 OGTTs with and without GLP-1 analogue

A standard OGTT will be performed and a second OGTT procedure will be repeated on a different day with GLP-1 analogue.

DRUG

Hyperglycemic clamp procedure

During the hyperglycemic clamp procedure, D20 will given, followed by phlebotomy.

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Brian G. Engelhardt, M.D. · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2023-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415139 on ClinicalTrials.gov