Prospective Study of Hormone Levels After Bariatric Surgery

Columbia University236 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

236

Conditions

Obesity

Interventions

Gastric bypassPROCEDURE

NOTE: Surgery will not be paid by the study

Gastric bandingPROCEDURE

NOTE: Surgery will not be paid by the study

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Change in body weight

linear mixed model analysis will be used to study change over time and between surgery

Time frame: 5 years

Data from ClinicalTrials.gov

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