Recruiting

Observational Study

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT03415139

Conditions

Diabetes Mellitus

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Oral Glucose Tolerance Test (OGTT)

2 OGTTs with and without GLP-1 analogue

Hyperglycemic clamp procedure

Study Details

Brief 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

Diabetes Mellitus

Cancer

Study ID

NCT03415139

Start date

Mar 12, 2019

Status verified date

Mar, 2022

Completion date

Apr, 2025

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria for Patients:

  • Patients undergoing allogeneic hematopoietic stem cell transplantation (HCT).

Exclusion Criteria for Patients:

  • Patients who have not received an allogeneic HCT
  • Recent or current history of diabetes mellitus, defined as:1) diabetes therapy within 6 months of enrollment, or 2) fasting blood glucose at "pre-admit" (screening) visit >= 126 mg/dL
  • Pregnancy or breastfeeding
  • Umbilical cord blood transplants
  • Patients on established, chronic corticosteroid therapy (> 10 mg /day of prednisone or prednisone equivalent) prior to transplant; established, chronic corticosteroid therapy is defined as daily dosing of > 10 mg/day of prednisone or prednisone equivalent for at least 2 weeks prior to the start of conditioning/chemotherapy or plans to continue pre-transplant corticosteroids (> 10 mg/day of prednisone or prednisone equivalent) indefinitely after transplantation
  • Inability to give informed consent
  • Any condition which, in the opinion of the investigator, might interfere with study objective
  • Any reason which, in the opinion of the investigator, adds additional risk to the patient

Additional exclusion criteria (Arms 1 and 2 Aim 1 only):

-Diagnosis of diabetes by standard oral glucose tolerance testing prior to transplant (2-hour plasma glucose value ≥ 200 mg/dL) in either Arm 1 or 2 will exclude further testing as per Aim 1. Immunological / metabolic testing as per Aim 2 will still be allowed

DONORS Inclusion Criteria for Donors (Arm 1 and Arm 2) Donors undergoing stem cell collection for related allogeneic stem cell transplant

Exclusion Criteria for Donors (Arms 1 and 2):

  • Individuals not donating stem cells
  • Pregnancy or breastfeeding
  • Inability to give informed consent
  • Any condition which, in the opinion of the investigator, might interfere with study objective

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm 1 for MRD HCT Recipients

Patients undergo an Oral Glucose Tolerance Test (OGTT) and 1 hyperglycemic clamp will be performed on separate days prior to transplant and then each procedure will be repeated once between day+80 to day+100 (+/- 10 days) after transplant.

Arm 2 for MRD HCT Recipients

Patients undergo 2 Oral Glucose Tolerance Test (OGTTs) (with and without GLP-1 analogue) will be performed on separate days prior to transplant and then each procedure will be repeated once between day+80 to day+100 (+/- 10 days) after transplant.

Interventions

Oral Glucose Tolerance Test (OGTT)

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

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.

Hyperglycemic clamp procedure

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

Primary outcome measure

  • Pre-transplant insulin secretion will be measured as glucose stimulated insulin secretion (GSIS) during a hyperglycemic clamp procedure among patients who do or do not go on to develop PTDM (univariable analysis). [ Time Frame: Up to 28 days pre-transplant ]
  • Pre-transplant insulin secretion will be measured as glucose stimulated insulin secretion (GSIS) during a hyperglycemic clamp procedure among patients who do or do not go on to develop PTDM (multivariable analysis). [ Time Frame: Up to 28 days pre-transplant ]
  • Post-transplant glucagon secretion will be measured during the oral glucose tolerance test among patients who do or do not develop PTDM (univariable analysis). [ Time Frame: Up to 100 days after transplant ]
  • Post-transplant glucagon secretion will be measured during the oral glucose tolerance test among patients who do or do not develop PTDM (multivariable analysis). [ Time Frame: Up to 100 days after transplant ]
  • Plasma IL-33 levels will be measured among patients who do or do not develop PTDM (univariable analysis). [ Time Frame: Up to 100 days after transplant ]
  • Plasma IL-33 levels will be measured among patients who do or do not develop PTDM (multivariable analysis). [ Time Frame: Up to 100 days after transplant ]

Central Contacts and Locations

Central contacts

VICC Clinical Trials Information Program

800-811-8480brian.engelhardt@vumc.org

Brian G. Engelhardt, M.D.

615 936-0381brian.engelhardt@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

VICC Clinical Trials Information Program

800-811-8480

Brian G. Engelhardt, M.D.

615-936-0381brian.engelhardt@vumc.org

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Mar 28, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2022-03-28.