Clinical trial NCT03141398: Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology Group
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Iron Overload
Hemoglobinopathies
Lymphoma
Acute Lymphoblastic Leukemia
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The targeted sample size is up to 100 patients (we aim to recruit approximately 70-100 cases based on the statistics from the outpatient clinics at NCCCR and the cancer registry data; over a period of 3 years). All cases of ALL, Lymphoma, Thalassemia and sickle cell disease diagnosed in HMC will be identified as subjects and they will be recruited based on informed consent and IRB approval.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hamad Medical Corporation
name: Mohamed Yassin
role: PRINCIPAL_INVESTIGATOR
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