Prospective Study of Hormone Levels After Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-17

Study Completion Date

2018-11-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery

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

Gastric bypass

Intervention Type PROCEDURE

NOTE: Surgery will not be paid by the study

Gastric banding

Intervention Type PROCEDURE

NOTE: Surgery will not be paid by the study

Interventions

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Gastric bypass

NOTE: Surgery will not be paid by the study

Intervention Type PROCEDURE

Gastric banding

NOTE: Surgery will not be paid by the study

Intervention Type PROCEDURE

Other Intervention Names

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GBP GB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes