Sickle Cell Disease, Sickle Cell Trait
Conditions
Keywords
Sickle Cell Disease (SCD), Sickle Cell Trait (SCT)
Brief summary
This is a cross-sectional, clinical research study comparing postmenopausal women of African Descent (AD) with different hemoglobin genotypes: normal and sickle cell trait (SCT). This research study has two purposes. The first purpose is to determine whether having SCT is a risk factor for the development of bone thinning in older women. The second purpose is to investigate whether women with SCT have reduced muscle function and increased frailty compared to women without SCT. The investigators estimate enrolling 50 female volunteers who are at least 50 years old and have not had a menstrual period for at least 12 consecutive months. Volunteers need not know whether they have SCT as this will be evaluated as part of the study.
Detailed description
This is a collaborative project involving three different disciplinary areas, including The Division of Hematology/Oncology, The Division of Endocrinology, and The Center on Aging (CoA)/Geriatrics in the UConn School of Medicine. The project consists of two specific aims: (1) determine effects of SCT on bone mineral density in postmenopausal women of African descent and (2) investigate the association of SCT on skeletal muscle function and frailty in postmenopausal women of African descent. The investigators hypothesize that individuals with SCT have reduced bone mineral density, decreased muscle function, and increased frailty compared to controls. This research may identify a hitherto unrecognized risk factor for racially disparate fracture incidence and outcomes in AD women. These findings will set the basis for a more extensive clinical study directly examining the association of SCT on fracture incidence and fracture-related morbidity and mortality.
Interventions
Participants will donate blood for serum bone turnover markers, complete blood count, calcium, phosphorus, albumin, parathyroid hormone, and hemoglobin electrophoresis. Participants will undergo a bone density evaluation and muscle mass measurement via dual-energy x-ray absorptiometry (DEXA) scanning. Participants will fill out dietary calcium intake and pain burden questionnaires. Participants will fill out a survey for frailty assessment, undergo 6-minute walk gait velocity and short physical performance battery (SPPB).
Participants will donate blood for serum bone turnover markers, complete blood count, calcium, phosphorus, albumin, parathyroid hormone, and hemoglobin electrophoresis. Participants will undergo a bone density evaluation and muscle mass measurement via dual-energy x-ray absorptiometry (DEXA) scanning. Participants will fill out dietary calcium intake and pain burden questionnaires. Participants will fill out a survey for frailty assessment, undergo 6-minute walk gait velocity and short physical performance battery (SPPB).
Sponsors
UConn Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female of African Decent. * Age 50 years or older. * Lack of menstrual period for at least 12 consecutive months
Exclusion criteria
* Taking medications known to influence bone metabolism (e.g., glucocorticoids, hormonal therapy, cancer or chemotherapy meds, anti-resorptive medications or anabolic therapies). * Known metabolic bone disorder (e.g., uncontrolled thyroid disease, hyperparathyroidism, Vitamin D deficiency) * Taking an investigational drug * Documented sickle cell disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in bone mineral density between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Day 1 | Particpants will undergo dual energy xray absorptiometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in calcium between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Day 1 | Participants will undergo blood testing to measure calcium levels in milligrams per deciliter. |
| Difference in parathyroid hormone between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Day 1 | Participants will undergo blood testing to measure parathyroid hormone levels in picograms per milliliter. |
| Difference in 25-OH vitamin D between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Day 1 | Participants will undergo blood testing to measure 25-OH Vitamin D levels in nanograms per milliliter. |
| Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women | Day 1 | Particpants will undergo dual energy xray absorptiometry to assess muscle mass. |
| Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women. | Day 1 | Participants will undergo a 6-minute walk and gait velocity. In addition, the short physical performance battery (SPPB) will be measured. The SPPB is an objective assessment tool for evaluating lower extremity functioning in older persons, balance, lower extremity strength, and functional capacity. |
| Effect of sickle cell trait (SCT) on frailty in older African descent (AD) women | Day 1 | Participants will have frailty assessed using both the Fried phenotype and the Rockwood Frailty Index. |
Countries
United States
Contacts
Primary ContactZoe Green, BS
Outcome results
None listed