Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study

Obesity Clinical Trial

— LIGH T  

Official title:

Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938808
• Other study ID #: H-B-2009-029
• Status: Completed
• Phase: N/A
• First received: July 13, 2009
• Last updated: January 15, 2016
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

Former participant in the CAROT study ( NCT00655941 )

Exclusion Criteria:

Bilateral knee alloplasty -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee
• Weight Loss

Intervention

Dietary Supplement:
• day formula diet
The Cambridge Programme. Formula diet

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Frederiksberg

Sponsors (5)

Lead Sponsor	Collaborator
Henning Bliddal	Cambridge Weight Plan Limited, Oak Foundation, The Danish Rheumatism Association, Velux Fonden

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. Review. — View 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. — View 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. Epub 2007 Jan 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight, number of patients operated with knee alloplasty		1 year, 3 years	No
Secondary	MRI		1 year, 3 years	No
Secondary	Gait analysis		1 year, 3 years	No
Secondary	Ultrasound		1 year, 3 years	No
Secondary	Collagen markers		1 year, 3 years	No
Secondary	Metabolic syndrome		1 year, 3 years	No
Secondary	KOOS		1 year, 3 years	No

External Links

•   Web page of the Parker Institute, Frederiksberg Hospital, Denmark