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Glucose Metabolism in Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02922296
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : June 13, 2023
Sponsor:
Information provided by (Responsible Party):
Victor Gordeuk, University of Illinois at Chicago

Study Description
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Brief Summary:

The purpose of the study is to better understand how the body handles sugars glucose and fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain persons at risk to develop diabetes. This understanding may help us to find new treatments to control blood sugar and prevent diabetes in people with and without sickle cell disease (SCD).

In this research, DNA and RNA will be isolated from blood cells. DNA will be used to find genes that cause or protect from diabetes, high cholesterol and high triglyceride, and RNA will be used for studies designed to find out how genes are doing their job of eventually producing proteins.


Condition or disease
Sickle Cell Disease Diabetes Mellitus

Detailed Description:

Sickle cell disease (SCD) is due to homozygosity for a Glu6Val mutation in HBB (sickle cell anemia; hemoglobin SS) or to compound heterozygous forms like hemoglobin SC disease and hemoglobin S-β thalassemia. Past studies suggested a low prevalence of diabetes in patients with SCD.10 Improvements in treatment and care have increased the life span of patients. This, along with the wide availability of high calorie diets and increasing adiposity in SCD raises that possibility that the prevalence of diabetes is increasing in SCD. Our study is designed to characterize the changes in metabolism that occur in sickle cell disease and to identify clinical, genetic and genomic risk factors for the development of diabetes. Our hypothesis is that non-overweight subjects with SCD have relative protection from diabetes and metabolic syndrome, but that those individuals who do become overweight have a dramatic increase in the rates of diabetes and metabolic syndrome. Lean SCD subjects will not have simply a neutral, but an overtly anti-diabetic phenotype (e.g. better glucose tolerance and lower metabolic syndrome markers). The two main study aims are as follows; Aim 1. Define the metabolic status of adult SCD subjects according to normal or increased BMI.

Aim 2. Determine genetic and genomic predictors of overweight, metabolic syndrome and diabetes in SCD subjects.

Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Glucose Metabolism in Sickle Cell Disease
Study Start Date : May 1, 2015
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Metabolic status of adult SCD subjects [ Time Frame: through study completion, approximately one year after subject participation ]

    The investigator will use the ATP III guidelines for definition of metabolic syndrome. A combination of any three of the following criteria will lead to the designation of metabolic syndrome:

    • waist circumference >102 cm (men) or >88 cm (women)
    • triglycerides ≥150 mg/dL
    • HDL cholesterol <40 mg/dL (men) or <50 mg/dL (women)
    • blood pressure ≥130/≥85 mg/dL (or recorded diagnosis of hypertension and use of antihypertensives)
    • fasting glucose ≥110 mg/dL (or diagnosis of diabetes and use of anti-diabetic medications)


Secondary Outcome Measures :
  1. Genetic and genomic predictors in SCD subjects [ Time Frame: through study completion, approximately one year after subject participation ]
    This will be accomplished by DNA linkage analysis and/or mutation analysis. In addition RNA will be isolated from from PBMCs and fractions of platelets, granulocytes and reticulocytes. The investigators will analyze the expression of transcripts to determine if alterations can explain the clinical observations.


Biospecimen Retention:   Samples With DNA
Blood samples will be stored temporarily in the laboratory of the Principal Investigator at the University of Illinois at Chicago, long term storage of specimens will be at the UIC Biobank. The research data will be stored in a locked file cabinet in the PI's research office. The patient's name or other identifying data will not be revealed, except to those directly involved in this study.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult sickle cell disease subjects, with or without diabetes.
Criteria

Inclusion Criteria:

  • Major sickling genotype (hemoglobin SS, Sbeta0-thalassemia, SOarab, SDpunjab)
  • Age >35 years
  • BMI <25 kg/m2 or >26 kg/m2
  • Steady state, defined as >two weeks from a hospitalization for vaso-occlusive crisis, infection or surgery and not requiring immediate parenteral medication for pain control
  • Fasting state (>8 hours since ingesting food or medication for diabetes)

Exclusion Criteria:

  • Patients receiving insulin therapy
  • Acute inflammatory or infectious illness or injury
Contacts and Locations
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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): NCT02922296


Contacts
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Contact: Victor Gordeuk, MD 312-996-5680 vgordeuk@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Victor Gordeuk, MD    312-996-5680    vgordeuk@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Victor Gordeuk, MD University of Illinois at Chicago
More Information
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Responsible Party: Victor Gordeuk, Director Sickle Cell Center, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02922296    
Other Study ID Numbers: 2015-0366
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: June 13, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn