Status:
COMPLETED
Skeletal Health in Bariatric Surgery Patients
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
American Society for Metabolic and Bariatric Surgery
Conditions:
Bariatric Surgery
Osteoporosis
Eligibility:
FEMALE
19+ years
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03331536
Start Date
March 22 2018
End Date
August 2 2020
Last Update
August 18 2020
Active Locations (1)
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1
UAB Kirklin Clinic Digestive Health Center
Birmingham, Alabama, United States, 35233