ObesityCT-OAMNCT02404090
Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations
An observational study of Obesity and Weight Loss, run by Marko Kraljevic.
Trial summary
Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Weight Loss, Knee Osteoarthritis
- What is being tested?
- CT-osteoarbsorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bariatric patients with BMI > 35 kg/m2 with knee pain (VAS > 2).
Who may be able to join
- BMI > 35
- need for bariatric operation
- knee pain (VAS > 2)
Who cannot join
- malignancy
- poor compliance
- previous bariatric operation
- pregnancy
- lack of knee pain (VAC < 2)
- previous knee operation
Trial locations and contacts
No sites are listed yet.
Marko Kraljevic, MD contact
About this study
Official title: Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations - a Prospective CT-osteoabsorptiometry-based Study
Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry.
- Conditions
- Obesity, Weight Loss, Knee Osteoarthritis
- Being tested
- CT-osteoarbsorptiometry
- Keywords
- Obesity, Weight Loss, Knee Osteoarthritis, Subchondral Mineralization
- Medical subject headings
- Obesity, Weight Loss, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-osteoarbsorptiometryRadiation
Conventional CT-scan analyzed by means of a specific tool (Analyze, Mayo Clinic).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineralization changes after excess weight loss?
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 posted31 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marko Kraljevic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marko Kraljevic, Spital Limmattal Schlieren
- Investigators
- Urs Zingg, MD, Principal investigator, Spital Limmattal Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404090
- Sponsor's protocol ID
- SLS-001
- Acronym
- CT-OAM
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations - a Prospective CT-osteoabsorptiometry-based Study
- ClinicalTrials.gov ID
- NCT02404090
- Acronym / sponsor ID
- CT-OAM / SLS-001
- Conditions
- Obesity, Weight Loss, Knee Osteoarthritis
- Keywords
- Obesity, Weight Loss, Knee Osteoarthritis, Subchondral Mineralization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marko KraljevicUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 31 Mar 2015 (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.
Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bariatric patients with BMI > 35 kg/m2 with knee pain (VAS > 2).
Key inclusion criteria (3 listed)
- BMI > 35
- need for bariatric operation
- knee pain (VAS > 2)
Key exclusion criteria (6 listed)
- malignancy
- poor compliance
- previous bariatric operation
- pregnancy
- lack of knee pain (VAC < 2)
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 |
|---|---|---|
| CT-osteoarbsorptiometryConventional CT-scan analyzed by means of a specific tool (Analyze, Mayo Clinic). | Radiation | – |
Primary outcome
Mineralization changes after excess weight loss?
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Marko Kraljevic, MD contact
Urs Zingg, MD principal investigator
Spital Limmattal Schlieren
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Weight Loss, run by Marko Kraljevic.
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 6 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: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko Kraljevic, MD (marko.kraljevic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mineralization changes after excess weight loss? (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 31 Mar 2015.