NCT03141398

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Iron Overload
• Hemoglobinopathies
• Lymphoma
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Continuous Glucose Monitoring (CGM)	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.
DIAGNOSTIC_TEST	Oral Glucose Tolerance Test (OGTT)	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.
DIAGNOSTIC_TEST	T2* MRI of the Pancreas	MRI \[Magnetic resonance imaging\] of the pancreas which is safe and takes around 30 minutes.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-08-01
• Completion: 2018-12-01
• First posted: 2017-05-05
• Last updated: 2017-07-26