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Trial record 2 of 2 for:    15618111 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03141398
Recruitment Status : Withdrawn (Due to issues with study design)
First Posted : May 5, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

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.

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort Intervention/treatment
High-Risk Group
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141398


Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Mohamed Yassin Hamad Medical Corporation

Publications:

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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03141398     History of Changes
Other Study ID Numbers: 16298/16
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Iron Overload
Hemoglobinopathies
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iron Metabolism Disorders
Metabolic Diseases
Hematologic Diseases
Genetic Diseases, Inborn
Pancrelipase
Pancreatin
Gastrointestinal Agents