Gastric Bypass SurgeryNCT03046147
The Effect of Roux-en-Y Gastric Bypass on Bone Turnover
An observational study of Gastric Bypass Surgery and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Bypass Surgery, Obesity, Bone Loss
- What is being tested?
- Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Sep 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from a previously investigated cohort of 20 subjects undergoing Roux-en-Y gastric bypass surgery (NCT 01202526). The previous study aimed at investigating acute and long term changes in insulin sensitivity and secretion, whereas the present follow-up study investigates changes in bone metabolism as the primary outcome.
Who may be able to join
- Participation in previos study ((NCT 01202526)
Who cannot join
- Treatment of osteoporosis
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University hospital Hvidovre
Copenhagen, 2820
Kirstine N Bojsen-Møller, MD, PhD, 4538626371, Kirstine.bojsen-moeller@regionh.dk
About this study
Official title: Bone Mineral Density and Markers of Bone Turnover After Roux-en-Y Gastric Bypass
Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal weight loss at 1 year and after weight stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be studied at fasting and during oral glucose tolerance test.
- Conditions
- Gastric Bypass Surgery, Obesity, Bone Loss
- Being tested
- Roux-en-Y gastric bypass
- Medical subject headings
- Obesity, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypassProcedure or surgery
Roux-en-Y gastric bypass surgery for morbid obesity
| Study group | Role | What they receive |
|---|---|---|
| RYGB patients with preoperative type diabetes | Recruited from a previously investigated cohort (NCT 01202526) Receives: Procedure: Roux-en-Y gastric bypass | |
| RYGB patients with preoperative normal glucose tolerance | Recruited from a previously investigated cohort (NCT 01202526) Receives: Procedure: Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density of non-weight bearing bone
DXA scans of forearm
Measured: 1 year, 4 years
Changes in bone mineral density of weightbearing bone
DXA scans of hip and lumbal columna
Measured: 1 year, 4 years
Secondary outcomes (2)
Plasma markers of bone turnover
At fasting
Measured: 1 week, 3 months, 1 year, 4 years
Plasma markers of bone turnover
during OGTT
Measured: 3 months, 1 year, 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startSep 2015
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Bypass SurgeryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046147
- Sponsor's protocol ID
- KBM-IS-Bone
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density and Markers of Bone Turnover After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT03046147
- Acronym / sponsor ID
- KBM-IS-Bone
- Conditions
- Gastric Bypass Surgery, Obesity, Bone Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Feb 2017 (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.
Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal weight loss at 1 year and after weight stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be studied at fasting and during oral glucose tolerance test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB patients with preoperative type diabetes | – | Procedure: Roux-en-Y gastric bypassRecruited from a previously investigated cohort (NCT 01202526) |
| RYGB patients with preoperative normal glucose tolerance | – | Procedure: Roux-en-Y gastric bypassRecruited from a previously investigated cohort (NCT 01202526) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from a previously investigated cohort of 20 subjects undergoing Roux-en-Y gastric bypass surgery (NCT 01202526). The previous study aimed at investigating acute and long term changes in insulin sensitivity and secretion, whereas the present follow-up study investigates changes in bone metabolism as the primary outcome.
Key inclusion criteria (1 listed)
- Participation in previos study ((NCT 01202526)
Key exclusion criteria (1 listed)
- Treatment of osteoporosis
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 |
|---|---|---|
| Roux-en-Y gastric bypassRoux-en-Y gastric bypass surgery for morbid obesity | Procedure or surgery | RYGB patients with preoperative normal glucose tolerance, RYGB patients with preoperative type diabetes |
Primary outcome
Changes in bone mineral density of non-weight bearing bone
Time frame: 1 year, 4 years
DXA scans of forearm
Changes in bone mineral density of weightbearing bone
Time frame: 1 year, 4 years
DXA scans of hip and lumbal columna
2 secondary outcomes
Plasma markers of bone turnover
Time frame: 1 week, 3 months, 1 year, 4 years
Plasma markers of bone turnover
Time frame: 3 months, 1 year, 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: No
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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.
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 Gastric Bypass Surgery and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 2017. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirstine N Bojsen-Møller, MD, PhD (4538626371, kirstine.bojsen-moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bone mineral density of non-weight bearing bone (time frame: 1 year, 4 years). The study lists 2 primary outcomes in all. 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 8 Feb 2017.