Prospective Study of Hormone Levels After Bariatric Surgery

September 18, 2019 updated by: Judith Korner, Columbia University

Prospective Study of Hormone Levels and Appetite After Bariatric Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery
Obese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding).
Procedure: Gastric bypass
NOTE: Surgery will not be paid by the study
Other Names:
  • GBP
Procedure: Gastric banding
NOTE: Surgery will not be paid by the study
Other Names:
  • GB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: 5 years
linear mixed model analysis will be used to study change over time and between surgery
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

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

Investigators

  • Principal Investigator: Judith Korner, MD,PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2003

Primary Completion (Actual)

November 4, 2018

Study Completion (Actual)

November 4, 2018

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAB0528
  • R01DK072011 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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