Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diabetes Mellitus

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

All Drugs and Chemicals

Gastrointestinal Agents

Hypoglycemic Agents

Glucagon-Like Peptide 1

Glucagon

Glucagon-Like Peptide-1 Receptor Agonists

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.

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.

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

Oral Glucose Tolerance Test (OGTT)

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

2 OGTTs with and without GLP-1 analogue

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

Hyperglycemic clamp procedure

VICC Clinical Trials Information Program

Brian G. Engelhardt, M.D.

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.

PRIMARY OBJECTIVES:

I. To determine if changes in islet cell physiology are detectable before or after matched related donor (MRD) hematopoietic stem cell transplant (HCT) in patients developing new-onset post-transplant diabetes mellitus (PTDM).

1. To determine if a compensatory increase in glucose stimulated insulin secretion (GSIS) by β-cells precedes PTDM development in patients without diabetes undergoing MRD HCT.
2. To determine if excess glucagon secretion and impaired α-cell response to glucose or GLP-1 contributes to the hyperglycemia of PTDM.

II. To determine if the IL-33/ST2 axis promotes immune/islet cell dysregulation during PTDM.

OUTLINE:

Patients undergo 2 OGTTs and a standard hyperglycemic clamp procedure prior to HCT. Patients then undergo repeat OGTTs and a hyperglycemic clamp procedure once after HCT between days 80-100.

Serum / plasma and peripheral blood mononuclear cells will be collected before and after hematopoietic stem cell transplant (HCT)

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

Islet Cell and ST2 Axis Dysregulation in Post-Transplant Diabetes Mellitus

A hyperglycemic clamp procedure will be performed pre-transplant. Pre-transplant will be defined as no more than 28 days before allogeneic hematopoietic cell transplantation. Patients will then be followed for 100 days after transplant for development of diabetes. In univariable analysis, a Wilcoxon rank sum test will be applied to compare the population mean difference in GSIS between these two groups.

A hyperglycemic clamp procedure will be performed pre-transplant. Pre-transplant will be defined as no more than 28 days before allogeneic hematopoietic cell transplantation. Patients will then be followed for 100 days after transplant for development of diabetes. In multivariable analysis, logistic regression will evaluate whether GSIS is an independent predictor of PTDM after adjusting for the following covariates: gender, conditioning (ablative vs. reduced intensity), or acute graft-versus-host disease (GVHD) requiring steroids. The estimated odds ratio (OR) and 95% confidence interval of the OR will be provided to measure the effect of the association.

Patients will be followed for 100 days after transplant for development of diabetes. In univariable analysis, a Wilcoxon rank sum test will be applied to compare the population mean difference in glucagon secretion between these two groups.

Patients will be followed for 100 days after transplant for development of diabetes. In multivariable analysis, a logistic regression will evaluate whether glucagon secretion is independently associated with PTDM after adjusting for the following covariates: gender, conditioning (ablative vs. reduced intensity), or acute graft-versus-host disease (GVHD) requiring steroids. The estimated odds ratio (OR) and 95% confidence interval of the OR will be provided to measure the effect of the association.

Patients will be followed for 100 days after transplant for development of diabetes. In univariable analysis, a Wilcoxon rank sum test will be applied to compare the population mean difference in IL-33 between these two groups.

In multivariable analysis, logistic regression will evaluate whether IL-33 is independently associated with PTDM after adjusting for the following covariates: gender, conditioning (ablative vs. reduced intensity), or acute graft-versus-host disease (GVHD) requiring steroids. The estimated odds ratio (OR) and 95% confidence interval of the OR will be provided to measure the effect of the association.

Vanderbilt-Ingram Cancer Center

Associate Professor of Medicine

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Syndrome

Glucose Intolerance

Polycystic Ovary Syndrome

Insulin Resistance

Cardiac Complexes, Premature

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Hyperglycemia

Hematinics

Insulin

Insulin, Globin Zinc

Liver Extracts

For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.

Oral glucose tolerance test (OGTT)

The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

1H-magnetic resonance spectroscopy

Alexandra Kautzky-Willer, Univ.Prof.Dr.

In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.

In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.

Glucose Metabolism in Different PCOS Phenotypes

Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance

In the present study the Glucose metabolism in PCOS women and control subjects was assessed with an OGTT. Therefore the dynamic levels of glucose, insulin and C-peptide were assessed during an extended OGTT for the calculation of Insulin resistance and beta-cell function. In addition an 1H-magnetic resonance spectroscopy was done for the assessment of the ectopic lipid content in the liver, heart and the skeletal muscle.

Medical University of Vienna

Univ.Prof.Dr.

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Iron Overload

Hemoglobinopathies

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Iron Metabolism Disorders

Genetic Diseases, Inborn

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Micronutrients

Iron

Pancrelipase

Pancreatin

The objective of the study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C. versus T2\* MRI of the pancreas (T2\* MRI of the Pancreas) in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance and to study the different factors that may affect the glycemic control in these patients in relation to their results like the Dose of corticosteroids and chemotherapy in ALL and Hemoglobinopathies,Liver function in ALL and Hemoglobinopathies, and Serum ferritin in Hemoglobinopathies and their transfusion status.

Where a pager-sized device fixed to the patient's forearm by a diabetic educator and it will connect to his/her body with the sensor, which measures blood glucose for three days. Patients' may experience little pain from needle prick when a sensor is introduced.

Continuous Glucose Monitoring (CGM)

Oral glucose tolerance test requires the patient to be fasting and checking of blood sugar after 8 to 10 hours overnight fasting the blood sugar will be checked three times When you arrive to the lab then twice one hour, apart you can have pain due to needle prick or little bleeding at the puncture site.

MRI \[Magnetic resonance imaging\] of the pancreas which is safe and takes around 30 minutes.

T2* MRI of the Pancreas

Mohamed Yassin

A prospective, observational, comparative study with no intervention.The objective of the study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C (Glycated Hemoglobin) and their relation to iron overload detected by T2\* MRI of the pancreas in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance and to study the different factors that may affect the glycemic control in these patients in relation to their results like the Dose of corticosteroids and chemotherapy in ALL and Hemoglobinopathies, Liver function in ALL and Hemoglobinopathies, and Serum ferritin in Hemoglobinopathies and their transfusion status. Using Validated Tools with Permission, the participants will be selected through probability (random) sampling method with expected subjects numbers ALL/L: 30-50, Thalassemia Major: 20, Sickle cell disease: 20.

Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology Group

Continuous Glucose Monitoring (CGM) Versus Oral Glucose Tolerance Test (OGTT) Versus T2* MRI Of The Pancreas In High-Risk Group (Hemoglobinopathies, Lymphoma & Acute Lymphoblastic Leukemia): A Comparative Study

Compare the efficiency of detecting glycemic abnormalities using CGMS versus OGTT vs HbA1C. in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance. Detect the prevalence of glycemic abnormalities detected in the same group of patients (high-risk patients) using three different modalities of testing (CGMS, OGTT, HbA1C)and T2\*MRI for pancreas

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant	NCT03415139	Diabetes Mellit... Cancer	Oral Glucose To... 2 OGTTs with an... Hyperglycemic c...	18 Years - 90 Years	Vanderbilt-Ingram Cancer Center
Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant	NCT03415139	Diabetes Mellit... Cancer	Oral Glucose To... 2 OGTTs with an... Hyperglycemic c...	18 Years - 90 Years	Vanderbilt-Ingram Cancer Center
Glucose Metabolism in Different PCOS Phenotypes	NCT03204461	Polycystic Ovar... Glucose Intoler... Liver Fat Glucose Metabol...	Oral glucose to... 1H-magnetic res...	20 Years - 40 Years	Medical University of Vienna
Glucose Metabolism in Different PCOS Phenotypes	NCT03204461	Polycystic Ovar... Glucose Intoler... Liver Fat Glucose Metabol...	Oral glucose to... 1H-magnetic res...	20 Years - 40 Years	Medical University of Vienna
Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology Group	NCT03141398	Iron Overload Hemoglobinopath... Lymphoma Acute Lymphobla...	Continuous Gluc... Oral Glucose To... T2* MRI of the ...	14 Years -	Hamad Medical Corporation
Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant	NCT03415139	Diabetes Mellit... Cancer	Oral Glucose To... 2 OGTTs with an... Hyperglycemic c...	18 Years - 90 Years	Vanderbilt-Ingram Cancer Center

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