Obesity in Pediatric Sickle Cell Disease: A New Phenomenon

NCT04676113 | Completed DMC

• 1 other identifier: 2020-0214
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Obesity, Childhood; Hypertension; Hyperlipidemia in Children; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Prevalence of Hypertension

  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

  12 months

Secondary Outcomes (2)

• Prevalence of Hyperlipidemia

  12 months

• Prevalence of Hyperglycemia

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

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MeSH Terms

Conditions

Anemia, Sickle Cell; Pediatric Obesity; Hypertension; Hyperglycemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 19, 2020
• Study Start: March 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)