Skeletal Health in Bariatric Surgery Patients

The University of Alabama at Birmingham

Status

Completed

Conditions

Osteoporosis

Premenopause

Menopause

Roux En-Y Gastric Bypass

Sleeve Gastrectomy

Bariatric Surgery

Fractures, Bone

Treatments

Procedure: Roux en Y Gastric Bypass Pre-menopausal

Procedure: Roux en Y Gastric Bypass Post-menopausal

Procedure: Sleeve Gastrectomy Post-menopausal

Procedure: Sleeve Gastrectomy Pre-menopausal

Study type

Observational

Funder types

Other

Identifiers

NCT03331536

IRB-300000701

Details and patient eligibility

About

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

Full description

While highly effective both RYGB and SG may lead to increased bone resorption, decreased bone mass, and increased risk of some fractures. Very few studies have compared the effects of the RYGB and the SG on changes skeletal health and findings have been inconsistent. Furthermore, few studies have investigated the short- or long-term consequences of bariatric surgery on bone mineral density in pre- and post-menopausal women. To what extent and how bariatric surgery impacts the skeleton largely remains undetermined. Because estrogen is protective against osteoporosis and fractures, the majority of fractures occur in postmenopausal women. It is important that women have higher rates of obesity (38.3%) compared to men (34.3%) and that ≥67% of bariatric patients are women. Therefore, women may be at a significantly increased risk of developing osteoporosis. These data may help establish clinical guidelines to assess, maintain, and promote skeletal health in the preoperative and postoperative care of bariatric patients; and it may help to determine the appropriate bariatric procedure for women at risk of osteoporosis and fractures.

Enrollment

27 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult females ≥ 19 years scheduled to undergo bariatric surgery (Roux en Y Gastric Bypass or Gastric Sleeve Surgery)
Class II (BMI 35-39.9 kg/m2).
Class III obesity (BMI ≥ 40 kg/m2).
Scheduled to undergo bariatric surgery with the ability to provide informed consent.

Exclusion criteria

Patients with a history of thyroid disorders, thyroidectomy and levothyroxine use.
Patients with a history of known osteoporosis, steroid-induced osteoporosis, current or previous use of medications for osteoporosis.
Patients with a history of gastrointestinal malabsorption.
Patients with a history of renal diseases.
Patients with a history of current or previous use of corticosteroids.
Patients who have used tobacco products within a year of study enrollment.
Patients with surgically-induced menopause e.g. bilateral salpingo-oophorectomy.
Patients with a history of breast cancer, who have had or are currently on hormonal therapy or anti-hormonal therapy.