Osteoarthritis, KneeLIGH TNCT00938808
Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
A study testing day formula diet in people with Osteoarthritis, Knee and Obesity, run by Henning Bliddal at 1 site in Denmark.
Trial summary
Obesity and osteoarthritis (OA) co-exist in an increasing part of the population. The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Obesity
- What is being tested?
- day formula diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Dec 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Former participant in the CAROT study ( NCT00655941 )
- -
Who cannot join
- Bilateral knee alloplasty -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute, Frederiksberg Hospital
Frederiksberg, Frederiksberg, 2000
About this study
Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.
The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.
There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial is an extension of the former CAROT trial NCT00655941. The participants of this trial are recruited for a prolongation of the dietary intervention consisting of a group therapy with low-energy diet in a randomized, two group (each n = 75 patients) study of maintenance of weight loss by continuing with supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. The hypothesis is that maintenance of the already induced weight loss is most efficiently ensured by the once-daily program.
Read the detailed description
Any patient with osteoarthritis (OA) of the knee was invited to participate in the preceding trial. Eligible for this study will be patients, who have completed the one-year phase 2 of the CAROT. Exclusion criteria are planned knee alloplasty of both knees.
- Conditions
- Osteoarthritis, Knee, Obesity
- Being tested
- day formula diet
- Keywords
- Osteoarthritis, Obesity, Weight loss, Dietary instruction, Formula diet, Attention
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Osteoarthritis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
day formula dietDietary supplement
The Cambridge Programme. Formula diet
| Study group | Role | What they receive |
|---|---|---|
| One per day, Formula diet | Active comparator | The Cambridge Programme. Formula diet One-daily Receives: Dietary Supplement: day formula diet |
| Repeated formula diet | Experimental | Dietary instruction (low-energy diet) 3x5 weeks per year Receives: Dietary Supplement: day formula diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight, number of patients operated with knee alloplasty
Measured: 1 year, 3 years
Secondary outcomes (6)
MRI
Measured: 1 year, 3 years
Gait analysis
Measured: 1 year, 3 years
Ultrasound
Measured: 1 year, 3 years
Collagen markers
Measured: 1 year, 3 years
Metabolic syndrome
Measured: 1 year, 3 years
KOOS
Measured: 1 year, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Bliddal
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
- Responsible party
- Sponsor-investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Henning Bliddal, Professor, Principal investigator, The P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938808
- Sponsor's protocol ID
- H-B-2009-029
- Acronym
- LIGH T
- Status last verified
- Jan 2016
- First submitted
- 13 Jul 2009
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.
PubMed 17204567Bliddal H, Christensen R. The management of osteoarthritis in the obese patient: practical considerations and guidelines for therapy. Obes Rev. 2006 Nov;7(4):323-31. doi: 10.1111/j.1467-789X.2006.00252.x.
PubMed 17038126Christensen R, Astrup A, Bliddal H. Weight loss: the treatment of choice for knee osteoarthritis? A randomized trial. Osteoarthritis Cartilage. 2005 Jan;13(1):20-7. doi: 10.1016/j.joca.2004.10.008.
PubMed 15639633Christensen P, Henriksen M, Bartels EM, Leeds AR, Meinert Larsen T, Gudbergsen H, Riecke BF, Astrup A, Heitmann BL, Boesen M, Christensen R, Bliddal H. Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial. Am J Clin Nutr. 2017 Sep;106(3):755-763. doi: 10.3945/ajcn.117.158543. Epub 2017 Jul 26.
PubMed 28747328
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
- ClinicalTrials.gov ID
- NCT00938808
- Acronym / sponsor ID
- LIGH T / H-B-2009-029
- Conditions
- Osteoarthritis, Knee, Obesity
- Keywords
- Osteoarthritis, Obesity, Weight loss, Dietary instruction, Formula diet, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Henning BliddalUniversity, hospital or other
- Collaborators
- Velux Fonden, Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jul 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.
Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.
The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.
There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial is an extension of the former CAROT trial NCT00655941. The participants of this trial are recruited for a prolongation of the dietary intervention consisting of a group therapy with low-energy diet in a randomized, two group (each n = 75 patients) study of maintenance of weight loss by continuing with supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. The hypothesis is that maintenance of the already induced weight loss is most efficiently ensured by the once-daily program.
Detailed description
Any patient with osteoarthritis (OA) of the knee was invited to participate in the preceding trial. Eligible for this study will be patients, who have completed the one-year phase 2 of the CAROT. Exclusion criteria are planned knee alloplasty of both knees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One per day, Formula diet | Active comparator | Dietary Supplement: day formula dietThe Cambridge Programme. Formula diet One-daily |
| Repeated formula diet | Experimental | Dietary Supplement: day formula dietDietary instruction (low-energy diet) 3x5 weeks per year |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Former participant in the CAROT study ( NCT00655941 )
- -
Key exclusion criteria (1 listed)
- Bilateral knee alloplasty -
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 |
|---|---|---|
| day formula dietThe Cambridge Programme. Formula diet | Dietary supplement | One per day, Formula diet, Repeated formula diet |
Primary outcome
Weight, number of patients operated with knee alloplasty
Time frame: 1 year, 3 years
6 secondary outcomes
MRI
Time frame: 1 year, 3 years
Gait analysis
Time frame: 1 year, 3 years
Ultrasound
Time frame: 1 year, 3 years
Collagen markers
Time frame: 1 year, 3 years
Metabolic syndrome
Time frame: 1 year, 3 years
KOOS
Time frame: 1 year, 3 years
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 18 Jan 2016.
- Background: PubMed 17204567Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.
- Background: PubMed 17038126Bliddal H, Christensen R. The management of osteoarthritis in the obese patient: practical considerations and guidelines for therapy. Obes Rev. 2006 Nov;7(4):323-31. doi: 10.1111/j.1467-789X.2006.00252.x.
- Background: PubMed 15639633Christensen R, Astrup A, Bliddal H. Weight loss: the treatment of choice for knee osteoarthritis? A randomized trial. Osteoarthritis Cartilage. 2005 Jan;13(1):20-7. doi: 10.1016/j.joca.2004.10.008.
- Derived from this study: PubMed 28747328Christensen P, Henriksen M, Bartels EM, Leeds AR, Meinert Larsen T, Gudbergsen H, Riecke BF, Astrup A, Heitmann BL, Boesen M, Christensen R, Bliddal H. Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial. Am J Clin Nutr. 2017 Sep;106(3):755-763. doi: 10.3945/ajcn.117.158543. Epub 2017 Jul 26.
- Web page of the Parker Institute, Frederiksberg Hospital, DenmarkLink provided by the sponsor.
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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.
Henning Bliddal, Professor principal investigator
The P
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing day formula diet in people with Osteoarthritis, Knee and Obesity, run by Henning Bliddal 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 2 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 18 Jan 2016. 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?
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?
Weight, number of patients operated with knee alloplasty (time frame: 1 year, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938808, which also lists 4 linked publications.
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 18 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.