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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers without SCT | Healthy women of African descent at least 50 years old without sickle cell trait and who have not had a menstrual period for at least 12 consecutive months. |
| |
| Healthy volunteers with SCT | Healthy women of African descent at least 50 years old with sickle cell trait and who have not had a menstrual period for at least 12 consecutive months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy volunteers without SCT | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in bone mineral density between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Particpants will undergo dual energy xray absorptiometry. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in 25-OH vitamin D between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Participants will undergo blood testing to measure 25-OH Vitamin D levels in nanograms per milliliter. | Day 1 |
| Difference in calcium between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal female volunteers of African Descent
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The target population includes healthy age-matched postmenopausal female volunteers of African Descent with and without SCT. Subjects will be eligible if they are at least 50 years old and have not had a menstrual period for at least 12 consecutive months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Green, BS | Contact | 860.679.4656 | zgreen@uchc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Biree Andemariam, MD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Recruiting | Farmington | Connecticut | 06030 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D012805 | Sickle Cell Trait |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Once informed consent and HIPAA authorization are obtained, a certified member of the research staff will perform the venipuncture for CBC, hemoglobin electrophoresis, blood serum bone turnover markers, phosphate, calcium, and vitamin D analysis. Research participants will donate approximately 12-15 cc of whole blood via venipuncture.
|
| Healthy volunteers with SCT | Other | 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 undergo blood testing to measure calcium levels in milligrams per deciliter. |
| Day 1 |
| Difference in parathyroid hormone between older African descent (AD) women with (N=25) and without (N=25) sickle cell trait (SCT) | Participants will undergo blood testing to measure parathyroid hormone levels in picograms per milliliter. | Day 1 |
| Effect of sickle cell trait (SCT) on frailty in older African descent (AD) women | Participants will have frailty assessed using both the Fried phenotype and the Rockwood Frailty Index. | Day 1 |
| Effect of sickle cell trait (SCT) on muscle mass in older African descent (AD) women | Particpants will undergo dual energy xray absorptiometry to assess muscle mass. | Day 1 |
| Effect of sickle cell trait (SCT) on muscle function in older African descent (AD) women. | 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. | Day 1 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |