Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology Group (CGMs)
|ClinicalTrials.gov Identifier: NCT03141398|
Recruitment Status : Withdrawn (Due to issues with study design)
First Posted : May 5, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment|
|Iron Overload Hemoglobinopathies Lymphoma Acute Lymphoblastic Leukemia||Diagnostic Test: Continuous Glucose Monitoring (CGM) Diagnostic Test: Oral Glucose Tolerance Test (OGTT) Diagnostic Test: T2* MRI of the Pancreas|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||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|
|Estimated Study Start Date :||August 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
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.
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.
- Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas [ Time Frame: 12 Months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141398
|Principal Investigator:||Mohamed Yassin||Hamad Medical Corporation|