Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
NCT ID: NCT00938808
Last Updated: 2016-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2009-06-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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One per day, Formula diet
The Cambridge Programme. Formula diet One-daily
day formula diet
The Cambridge Programme. Formula diet
Repeated formula diet
Dietary instruction (low-energy diet) 3x5 weeks per year
day formula diet
The Cambridge Programme. Formula diet
Interventions
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day formula diet
The Cambridge Programme. Formula diet
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Velux Fonden
OTHER
Oak Foundation
OTHER
The Danish Rheumatism Association
OTHER
Cambridge Weight Plan Limited
INDUSTRY
Henning Bliddal
OTHER
Responsible Party
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Henning Bliddal
Professor
Principal Investigators
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Henning Bliddal, Professor
Role: PRINCIPAL_INVESTIGATOR
The P
Locations
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The Parker Institute, Frederiksberg Hospital
Frederiksberg, Frederiksberg, Denmark
Countries
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References
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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.
Bliddal 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.
Christensen 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.
Christensen 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.
Related Links
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Web page of the Parker Institute, Frederiksberg Hospital, Denmark
Other Identifiers
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H-B-2009-029
Identifier Type: -
Identifier Source: org_study_id
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