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CompletedNCT00627315Updated Sep 19, 2019

Prospective Study of Hormone Levels After Bariatric Surgery

An observational study in Obesity, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Columbia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
236
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Insulin Resistance
  • Bariatric Surgery
  • Gastric Banding
  • Gastric Bypass
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 236 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
236 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Surgery

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

    Procedure: Gastric bypass · Procedure: Gastric banding

Interventions

  • ProcedureGastric bypass

    NOTE: Surgery will not be paid by the study

    Also known as: GBP

  • ProcedureGastric banding

    NOTE: Surgery will not be paid by the study

    Also known as: GB

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What researchers measure

Primary outcomes

  1. Change in body weight

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

    Time frame: 5 years

07

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00627315
Lead sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Judith Korner (Associate Professor of Medicine, Columbia University) — Principal investigator
First posted
Mar 3, 2008
Start date
Mar 17, 2003
Primary completion
Nov 4, 2018
Completion
Nov 4, 2018
Last update
Sep 19, 2019

Study contacts

Judith Korner, MD,PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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