FaminePhase 1NCT00967122
Band Holiday Study
A Phase 1 study testing Band adjustment and specimen collection in people with Famine, run by NYU Langone Health at 1 site in United States.
Trial summary
AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Famine
- What is being tested?
- Band adjustment and specimen collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2012
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age
- who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and
- agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate.
Who cannot join
- < %35 Excess weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lap Band Adjustment on Satiety Peptides
AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.
Read the detailed description
AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.
Materials and Methods:
Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.
Sample size:
For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.
- Conditions
- Famine
- Being tested
- Band adjustment and specimen collection
- Keywords
- adjustment, hunger, Hunger/satiety changes before and after gastric band adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Band adjustment and specimen collectionProcedure or surgery
Clinical evaluation and sample collection before and after band adjustment
| Study group | Role | What they receive |
|---|---|---|
| No Arm | No intervention | Not described Receives: Procedure: Band adjustment and specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of representative hormones of hunger and satiety
Measured: 2 weeks
Secondary outcomes (1)
surveying hunger/satiety and behavior changes.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FamineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heekoung A Youn, NYU Langone Health
- Investigators
- Francois Fritz, M.D., Principal investigator, NYUSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967122
- Sponsor's protocol ID
- NYUSWLP-BH
- Status last verified
- Sep 2012
- First submitted
- 25 Aug 2009
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lap Band Adjustment on Satiety Peptides
- ClinicalTrials.gov ID
- NCT00967122
- Acronym / sponsor ID
- NYUSWLP-BH
- Conditions
- Famine
- Keywords
- adjustment, hunger, Hunger/satiety changes before and after gastric band adjustment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Aug 2009 (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.
AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.
Detailed description
AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.
Materials and Methods:
Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.
Sample size:
For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Arm | No intervention | Procedure: Band adjustment and specimen collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 years of age
- who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and
- agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate.
Key exclusion criteria (1 listed)
- < %35 Excess weight loss
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 |
|---|---|---|
| Band adjustment and specimen collectionClinical evaluation and sample collection before and after band adjustment | Procedure or surgery | No Arm |
Primary outcome
plasma concentrations of representative hormones of hunger and satiety
Time frame: 2 weeks
1 secondary outcome
surveying hunger/satiety and behavior changes.
Time frame: 2 weeks
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 27 Sep 2012.
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.
Francois Fritz, M.D. principal investigator
NYUSOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Band adjustment and specimen collection in people with Famine, run by NYU Langone Health 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 3 inclusion and 1 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 27 Sep 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
plasma concentrations of representative hormones of hunger and satiety (time frame: 2 weeks). 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 27 Sep 2012.