OsteoarthrtisBIO-LOSEIT-INCT02931344
Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss
A study testing Dietary Supplement: Dietary Supplement: Intensive dietary intervention in people with Osteoarthrtis and Obesity, run by Henrik Gudbergsen at 1 site in Denmark.
Trial summary
This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Osteoarthrtis, Obesity
- What is being tested?
- Dietary Supplement: Dietary Supplement: Intensive dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Jun 2019
- Phase
- Interventional
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Same as parent trial (NCT02905864)
Who cannot join
- Same as parent trial (NCT02905864)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss
This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).
This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention
Read the detailed description
In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
- Conditions
- Osteoarthrtis, Obesity
- Being tested
- Dietary Supplement: Dietary Supplement: Intensive dietary intervention
- Keywords
- Osteoarthrtis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Dietary Supplement: Intensive dietary interventionDietary supplement
Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
| Study group | Role | What they receive |
|---|---|---|
| Intensive dietary intervention | Experimental | Supervised dietary weight loss program lasting 8 weeks Receives: Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in collagen II degradation fragment α-C2M
Blood sampling
Measured: Week -8 to 0
Secondary outcomes (5)
Change in collagen II degradation fragment β-C2M
Blood sampling
Measured: Week -8 to 0
Change in non-coding RNA type snoRNAs U38 and U48
Blood sampling
Measured: Week -8 to 0
Change in miRNA-454
Blood sampling
Measured: Week -8 to 0
Change in miRNA let-7e
Blood sampling
Measured: Week -8 to 0
Change in Nesfatin-1
Blood sampling
Measured: Week -8 to 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrtisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Gudbergsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Gudbergsen, Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931344
- Sponsor's protocol ID
- 137.04
- Acronym
- BIO-LOSEIT-I
- Status last verified
- Apr 2018
- First submitted
- 23 Sep 2016
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss
- ClinicalTrials.gov ID
- NCT02931344
- Acronym / sponsor ID
- BIO-LOSEIT-I / 137.04
- Conditions
- Osteoarthrtis, Obesity
- Keywords
- Osteoarthrtis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henrik GudbergsenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 13 Oct 2016 (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 is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).
This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention
Detailed description
In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive dietary intervention | Experimental | Dietary Supplement: Dietary Supplement: Dietary Supplement: Intensive dietary interventionSupervised dietary weight loss program lasting 8 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Same as parent trial (NCT02905864)
Key exclusion criteria (1 listed)
- Same as parent trial (NCT02905864)
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 |
|---|---|---|
| Dietary Supplement: Dietary Supplement: Intensive dietary interventionParticipants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met. | Dietary supplement | Intensive dietary intervention |
Primary outcome
Change in collagen II degradation fragment α-C2M
Time frame: Week -8 to 0
Blood sampling
5 secondary outcomes
Change in collagen II degradation fragment β-C2M
Time frame: Week -8 to 0
Change in non-coding RNA type snoRNAs U38 and U48
Time frame: Week -8 to 0
Change in miRNA-454
Time frame: Week -8 to 0
Change in miRNA let-7e
Time frame: Week -8 to 0
Change in Nesfatin-1
Time frame: Week -8 to 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Dietary Supplement: Intensive dietary intervention in people with Osteoarthrtis and Obesity, run by Henrik Gudbergsen 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 23 Apr 2018. 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?
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 collagen II degradation fragment α-C2M (time frame: Week -8 to 0). 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 23 Apr 2018.