ObesityNCT00627315
Prospective Study of Hormone Levels After Bariatric Surgery
An observational study of Obesity, run by Columbia University at 1 site in United States.
Trial summary
This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Gastric bypass and Gastric banding
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2003to 4 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult male or female > 18 years of age
- Scheduled to undergo bariatric surgery
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
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.
- Conditions
- Obesity
- Being tested
- Gastric bypass, Gastric banding
- Keywords
- Obesity, Insulin Resistance, Bariatric Surgery, Gastric Banding, Gastric Bypass
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Also called GBP
NOTE: Surgery will not be paid by the study
Gastric bandingProcedure or surgery
Also called GB
NOTE: Surgery will not be paid by the study
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Obese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding). Receives: Procedure: Gastric bypass; Procedure: Gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
linear mixed model analysis will be used to study change over time and between surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study start17 Mar 2003
- Primary completion4 Nov 2018
- Study completion4 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Korner, Columbia University
- Investigators
- Judith Korner, MD,PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627315
- Sponsor's protocol ID
- AAAB0528
- Other IDs
- R01DK072011
- Status last verified
- Sep 2019
- First submitted
- 28 Feb 2008
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Hormone Levels and Appetite After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00627315
- Acronym / sponsor ID
- AAAB0528
- Conditions
- Obesity
- Keywords
- Obesity, Insulin Resistance, Bariatric Surgery, Gastric Banding, Gastric Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Mar 2003 (actual)
- Primary completion
- 4 Nov 2018 (actual)
- Study completion
- 4 Nov 2018 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: Gastric bypass, Procedure: Gastric bandingObese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult male or female > 18 years of age
- Scheduled to undergo bariatric surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypassAlso: GBPNOTE: Surgery will not be paid by the study | Procedure or surgery | Surgery |
| Gastric bandingAlso: GBNOTE: Surgery will not be paid by the study | Procedure or surgery | Surgery |
Primary outcome
Change in body weight
Time frame: 5 years
linear mixed model analysis will be used to study change over time and between surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Korner, MD,PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.