Prospective Study of Hormone Levels After Bariatric Surgery

Columbia University

Status: Completed

Conditions: Obesity

Treatments: Procedure: Gastric banding; Procedure: Gastric bypass

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00627315

AAAB0528

R01DK072011 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.

Full description

Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure. The groups will not be randomized. Rather, they will decide on their choice of surgery along with their physicians. The patients will be evaluated pre-operatively and followed post-operatively for 5 years.

Initial evaluation will include a complete history and physical examination, measurement of calcium, parathyroid hormone (PTH) and vitamin D, and assessment of skeletal health using markers of bone turnover and bone mineral density.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult male or female > 18 years of age
2. Scheduled to undergo bariatric surgery

Exclusion criteria

1. Vitamin D deficiency
2. Primary hyperparathyroidism
3. Treatment with lithium or thiazide diuretics which may alter PTH levels
4. Osteomalacia
5. Untreated hyperthyroidism, liver disease, Cushing's syndrome, rheumatoid arthritis, myeloma or Paget's disease
6. Impaired renal function (serum creatinine >2.0mg/dl) or history of renal osteodystrophy
7. Use of any anti-obesity medications for over 2 weeks 90 days prior to study
8. Participation in any research study 90 days prior to study
9. Any malabsorption syndromes such as celiac sprue
10. Previous bariatric surgery

Trial design

236 participants in 1 patient group

Surgery

Description:

Obese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding).

Treatment:

Procedure: Gastric bypass

Procedure: Gastric banding