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Obesity in Pediatric Sickle Cell Disease: A New Phenomenon

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ClinicalTrials.gov Identifier: NCT04676113
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Erin Jackson, University of Mississippi Medical Center

Brief Summary:
The objective of this project is to determine the prevalence of hypertension, hyperlipidemia and hyperglycemia in the pediatric population with sickle cell disease who are obese in Mississippi compared to those pediatric patients with sickle cell disease who are not overweight/obese. The pediatric hematology department at the University of Mississippi Medical Center (UMMC) has a relatively large population of patients with sickle cell disease who are overweight and obese. This is a paradoxical trend since high-energy expenditure of the body to produce new red blood cells usually results in underweight to normal weight patients. From our previous chart review, the investigators found our pediatric patients with sickle cell disease to have similar rates of overweight and obesity to that of state and national levels. The metrics our team will measure include: blood pressure, blood cholesterol levels and blood glucose levels. The investigators expect to find higher rates of hypertension, high cholesterol and high glucose levels in the overweight and obese patients with SCD compared to that of underweight and normal weight. Our ultimate goal for follow up projects will be to determine the baseline risk of hypertension, hyperlipidemia and hyperglycemia in this population so we can then determine effective, sustainable interventions for weight and the co-morbidities that come with increasing weight status. Our goal would also be to educate the patient and families on these interventions and provide them with resources, which could lead to an overall improvement in health and patients quality of life.

Condition or disease
Sickle Cell Disease Obesity, Childhood Hypertension Hyperlipidemia in Children Hyperglycemia

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Obesity in Pediatric Sickle Cell Disease: A New Phenomenon
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Group/Cohort
Pediatric Patients with Sickle Disease who are overweight/obese
Pediatric Patients age 10-19 years diagnosed with Sickle cell disease who have a BMI of >85%ile.
Pediatric Patients with Sickle Cell Disease who are underweight/normal weight
Pediatric Patients age 10-19 years diagnosed with Sickle Cell disease who have a BMI<85%ile.



Primary Outcome Measures :
  1. Prevalence of Hypertension [ Time Frame: 12 months ]
    To assess the prevalence of hypertension of pediatric sickle cell disease in patients who are overweight/obese compared to those who are underweight/normal weight


Secondary Outcome Measures :
  1. Prevalence of Hyperlipidemia [ Time Frame: 12 months ]
    To assess the prevalence of high cholesterol of pediatric sickle cell disease in patients who are overweight/obese compared to those who are underweight/normal weight

  2. Prevalence of Hyperglycemia [ Time Frame: 12 months ]
    To assess the prevalence of hyperglycemia of pediatric sickle cell disease in patients who are overweight/obese compared to those who are underweight/normal weight



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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The UMMC Pediatric Sickle Cell Clinic is the only specialty pediatric SCD clinic in Mississippi. It is one of the largest pediatric SCD programs in the nations, serving approximately 800 patients annually throughout the state of Mississippi. Pediatric SCD clinic is held twice weekly on the UMMC main campus in Jackson, MS. There is also a multidisciplinary clinic twice monthly and satellite clinics in Hattiesburg, Meridian and Gulfport, MS. Pediatric patients and a primary caregiver/parent (parent) (>21 years old) will be recruited from the UMMC main campus.
Criteria

Inclusion Criteria:

  • 10-19 years
  • diagnosed with SCD genotype HbSS, HbSβ0, HbSC, or HbSβ+
  • regularly followed by the UMMC Pediatric SCD clinic (i.e., average visit at least once per year in past two years)

Exclusion Criteria:

  • non-English speaking
  • patient in acute vaso-occlusive pain crisis (which can increase blood pressure)
  • cognitive or developmental delays that preclude ability to complete study questionnaires

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): NCT04676113


Contacts
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Contact: Erin Jackson, MD 601-984-5220 eajackson@umc.edu

Sponsors and Collaborators
University of Mississippi Medical Center
Publications:

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Responsible Party: Erin Jackson, Principle Investigator, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT04676113    
Other Study ID Numbers: 2020-0214
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Obesity
Hyperglycemia
Hyperlipidemias
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders