Hypertension Clinical Trial
Official title:
Obesity in Pediatric Sickle Cell Disease: A New Phenomenon
NCT number | NCT04676113 |
Other study ID # | 2020-0214 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | June 30, 2022 |
Verified date | May 2023 |
Source | University of Mississippi Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 19 Years |
Eligibility | Inclusion Criteria: - 10-19 years - diagnosed with SCD genotype HbSS, HbSß0, HbSC, or HbSß+ - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Mississippi Medical Center | Jackson | Mississippi |
Lead Sponsor | Collaborator |
---|---|
University of Mississippi Medical Center |
United States,
Anderson PM, Butcher KE. Childhood obesity: trends and potential causes. Future Child. 2006 Spring;16(1):19-45. doi: 10.1353/foc.2006.0001. — View Citation
Arluk SL, Branch JD, Swain DP, Dowling EA. Childhood obesity's relationship to time spent in sedentary behavior. Mil Med. 2003 Jul;168(7):583-6. — View Citation
Brady LM, Lindquist CH, Herd SL, Goran MI. Comparison of children's dietary intake patterns with US dietary guidelines. Br J Nutr. 2000 Sep;84(3):361-7. — View Citation
Chawla A, Sprinz PG, Welch J, Heeney M, Usmani N, Pashankar F, Kavanagh P. Weight status of children with sickle cell disease. Pediatrics. 2013 Apr;131(4):e1168-73. doi: 10.1542/peds.2012-2225. Epub 2013 Mar 4. — View Citation
Cheung EL, Bell CS, Samuel JP, Poffenbarger T, Redwine KM, Samuels JA. Race and Obesity in Adolescent Hypertension. Pediatrics. 2017 May;139(5):e20161433. doi: 10.1542/peds.2016-1433. Epub 2017 Apr 10. — View Citation
Daniels SR, Greer FR; Committee on Nutrition. Lipid screening and cardiovascular health in childhood. Pediatrics. 2008 Jul;122(1):198-208. doi: 10.1542/peds.2008-1349. — View Citation
Desai PC, Deal AM, Brittain JE, Jones S, Hinderliter A, Ataga KI. Decades after the cooperative study: a re-examination of systemic blood pressure in sickle cell disease. Am J Hematol. 2012 Oct;87(10):E65-8. doi: 10.1002/ajh.23278. Epub 2012 Jun 20. — View Citation
Dileepan K, Feldt MM. Type 2 diabetes mellitus in children and adolescents. Pediatr Rev. 2013 Dec;34(12):541-8. doi: 10.1542/pir.34-12-541. — View Citation
Gurnani M, Birken C, Hamilton J. Childhood Obesity: Causes, Consequences, and Management. Pediatr Clin North Am. 2015 Aug;62(4):821-40. doi: 10.1016/j.pcl.2015.04.001. Epub 2015 May 23. — View Citation
Hall R, Gardner K, Rees DC, Chakravorty S. High body mass index in children with sickle cell disease: a retrospective single-centre audit. BMJ Paediatr Open. 2018 Oct 23;2(1):e000302. doi: 10.1136/bmjpo-2018-000302. eCollection 2018. — View Citation
Hannon TS, Arslanian SA. The changing face of diabetes in youth: lessons learned from studies of type 2 diabetes. Ann N Y Acad Sci. 2015 Sep;1353:113-37. doi: 10.1111/nyas.12939. Epub 2015 Oct 8. — View Citation
Hannon TS, Gungor N, Arslanian SA. Type 2 diabetes in children and adolescents: a review for the primary care provider. Pediatr Ann. 2006 Dec;35(12):880-7. doi: 10.3928/0090-4481-20061201-02. No abstract available. — View Citation
Hardy SJ, Bills SE, Wise SM, Hardy KK. Cognitive Abilities Moderate the Effect of Disease Severity on Health-Related Quality of Life in Pediatric Sickle Cell Disease. J Pediatr Psychol. 2018 Sep 1;43(8):882-894. doi: 10.1093/jpepsy/jsy019. — View Citation
Ihmels MA, Welk GJ, Eisenmann JC, Nusser SM, Myers EF. Prediction of BMI change in young children with the family nutrition and physical activity (FNPA) screening tool. Ann Behav Med. 2009 Aug;38(1):60-8. doi: 10.1007/s12160-009-9126-3. Epub 2009 Oct 6. — View Citation
Karlson CW, Delozier AM, Seals SR, Britt AB, Stone AL, Reneker JC, Jackson EA, McNaull MM, Credeur DP, Welsch MA. Physical Activity and Pain in Youth With Sickle Cell Disease. Fam Community Health. 2020 Jan/Mar;43(1):1-9. doi: 10.1097/FCH.0000000000000241. — View Citation
Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27. — View Citation
Lioret S, Volatier JL, Lafay L, Touvier M, Maire B. Is food portion size a risk factor of childhood overweight? Eur J Clin Nutr. 2009 Mar;63(3):382-91. doi: 10.1038/sj.ejcn.1602958. Epub 2007 Nov 21. — View Citation
Malik VS, Schulze MB, Hu FB. Intake of sugar-sweetened beverages and weight gain: a systematic review. Am J Clin Nutr. 2006 Aug;84(2):274-88. doi: 10.1093/ajcn/84.1.274. — View Citation
Mulhern RK, Palmer SL, Reddick WE, Glass JO, Kun LE, Taylor J, Langston J, Gajjar A. Risks of young age for selected neurocognitive deficits in medulloblastoma are associated with white matter loss. J Clin Oncol. 2001 Jan 15;19(2):472-9. doi: 10.1200/JCO.2001.19.2.472. — View Citation
National High Blood Pressure Education Program Working Group report on hypertension in diabetes. Hypertension. 1994 Feb;23(2):145-58; discussion 159-60. — View Citation
Ogunsile FJ, Bediako SM, Nelson J, Cichowitz C, Yu T, Patrick Carroll C, Stewart K, Naik R, Haywood C Jr, Lanzkron S. Metabolic syndrome among adults living with sickle cell disease. Blood Cells Mol Dis. 2019 Feb;74:25-29. doi: 10.1016/j.bcmd.2018.10.005. Epub 2018 Oct 22. — View Citation
Pegelow CH, Colangelo L, Steinberg M, Wright EC, Smith J, Phillips G, Vichinsky E. Natural history of blood pressure in sickle cell disease: risks for stroke and death associated with relative hypertension in sickle cell anemia. Am J Med. 1997 Feb;102(2):171-7. doi: 10.1016/s0002-9343(96)00407-x. — View Citation
Pikilidou M, Yavropoulou M, Antoniou M, Papakonstantinou E, Pantelidou D, Chalkia P, Nilsson P, Yovos J, Zebekakis P. Arterial Stiffness and Peripheral and Central Blood Pressure in Patients With Sickle Cell Disease. J Clin Hypertens (Greenwich). 2015 Sep;17(9):726-31. doi: 10.1111/jch.12572. Epub 2015 May 20. — View Citation
Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303. — View Citation
Pujalte GGA, Ahanogbe I, Thurston MJ, White RO, Roche-Green A. Addressing Pediatric Obesity in Clinic. Glob Pediatr Health. 2017 Oct 30;4:2333794X17736971. doi: 10.1177/2333794X17736971. eCollection 2017. — View Citation
Rhodes M, Akohoue SA, Shankar SM, Fleming I, Qi An A, Yu C, Acra S, Buchowski MS. Growth patterns in children with sickle cell anemia during puberty. Pediatr Blood Cancer. 2009 Oct;53(4):635-41. doi: 10.1002/pbc.22137. — View Citation
Ribeiro RT, Macedo MP, Raposo JF. HbA1c, Fructosamine, and Glycated Albumin in the Detection of Dysglycaemic Conditions. Curr Diabetes Rev. 2016;12(1):14-9. doi: 10.2174/1573399811666150701143112. — View Citation
Siddiqui S, Malatesta-Muncher R. Hypertension in Children and Adolescents: A Review of Recent Guidelines. Pediatr Ann. 2020 Jun 1;49(6):e250-e257. doi: 10.3928/19382359-20200513-01. — View Citation
Simental-Mendia LE, Rodriguez-Moran M, Aradillas-Garcia C, Guerrero-Romero F. Hypertriglyceridemia is associated with impaired fasting glucose in normal-weight children. Pediatr Res. 2018 Sep;84(3):352-355. doi: 10.1038/s41390-018-0027-7. Epub 2018 Jul 3. — View Citation
Singhal A, Davies P, Sahota A, Thomas PW, Serjeant GR. Resting metabolic rate in homozygous sickle cell disease. Am J Clin Nutr. 1993 Jan;57(1):32-4. doi: 10.1093/ajcn/57.1.32. — View Citation
Small L, Bonds-McClain D, Gannon AM. Physical activity of young overweight and obese children: parent reports of child activity level compared with objective measures. West J Nurs Res. 2013 May;35(5):638-54. doi: 10.1177/0193945912471976. Epub 2013 Jan 8. — View Citation
Tanner JM, Davies PS. Clinical longitudinal standards for height and height velocity for North American children. J Pediatr. 1985 Sep;107(3):317-29. doi: 10.1016/s0022-3476(85)80501-1. — View Citation
Vendrame F, Olops L, Saad STO, Costa FF, Fertrin KY. Hypocholesterolemia and dysregulated production of angiopoietin-like proteins in sickle cell anemia patients. Cytokine. 2019 Aug;120:88-91. doi: 10.1016/j.cyto.2019.04.014. Epub 2019 May 1. — View Citation
Zhou J, Han J, Nutescu EA, Galanter WL, Walton SM, Gordeuk VR, Saraf SL, Calip GS. Similar burden of type 2 diabetes among adult patients with sickle cell disease relative to African Americans in the U.S. population: a six-year population-based cohort analysis. Br J Haematol. 2019 Apr;185(1):116-127. doi: 10.1111/bjh.15773. Epub 2019 Feb 3. — View Citation
Zhou J, Han J, Nutescu EA, Galanter WL, Walton SM, Gordeuk VR, Saraf SL, Calip GS. Type 2 diabetes in adults with sickle cell disease: can we dive deeper? Response to Skinner et al. Br J Haematol. 2019 Sep;186(5):782-783. doi: 10.1111/bjh.15949. Epub 2019 May 8. No abstract available. — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Prevalence of Hyperlipidemia | 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 | 12 months | |
Secondary | Prevalence of Hyperglycemia | 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 | 12 months |
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