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

Hamad Medical Corporation (HMC)

Status: Withdrawn

Conditions: Hemoglobinopathies; Iron Overload; Lymphoma; Acute Lymphoblastic Leukemia

Treatments: Diagnostic Test: Continuous Glucose Monitoring (CGM); Diagnostic Test: T2* MRI of the Pancreas; Diagnostic Test: Oral Glucose Tolerance Test (OGTT)

Study type: Observational

Funder types: Industry

Identifiers

NCT03141398

16298/16

Details and patient eligibility

About

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.

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• This study will include participants who are High-risk patients to develop glycemic abnormalities:

  1. Thalassemia major and SCD (beta cell toxicity and hepatic siderosis)
  2. ALL/L ( beta cell injury and hepatic injury due to chemotherapy, and insulin resistance due to corticosteroids)

Exclusion criteria

• Age < 14 years;
• Other systemic diseases, renal disorders or malnourished;
• Patients and unwilling to participate in the study.

Trial design

0 participants in 1 patient group

High-Risk Group

Description:

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.

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test (OGTT)

Diagnostic Test: T2* MRI of the Pancreas

Diagnostic Test: Continuous Glucose Monitoring (CGM)