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OpenTrials
Completed

NCT Number: NCT00627315

Prospective Study of Hormone Levels After Bariatric Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female > 18 years of age
  • Scheduled to undergo bariatric surgery

Exclusion criteria

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

Treatment and study plan

Gastric bypass

Procedure

NOTE: Surgery will not be paid by the study

Other names: GBP

Gastric Banding

Procedure

NOTE: Surgery will not be paid by the study

Other names: GB

Primary outcomes

  1. Change in body weight

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Prospective Study of Hormone Levels and Appetite After Bariatric Surgery

Important dates

Study start
2003
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2008
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.