Clinical trial NCT00938808: Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
Official title: Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Obesity
Keywords: Osteoarthritis
Obesity
Weight loss
Dietary instruction
Formula diet
Attention
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Oak Foundation
name: The Danish Rheumatism Association
name: Cambridge Weight Plan Limited
First posted: 2009-07-14
Enrollment: 154
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Former participant in the CAROT study ( NCT00655941 )

-

Exclusion Criteria:

Bilateral knee alloplasty -

Primary outcomes:
measure: Weight, number of patients operated with knee alloplasty
timeFrame: 1 year, 3 years
Secondary outcomes:
measure: MRI
timeFrame: 1 year, 3 years
measure: Gait analysis
timeFrame: 1 year, 3 years
measure: Ultrasound
timeFrame: 1 year, 3 years
measure: Collagen markers
timeFrame: 1 year, 3 years
measure: Metabolic syndrome
timeFrame: 1 year, 3 years
measure: KOOS
timeFrame: 1 year, 3 years
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: The P
name: Henning Bliddal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.