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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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

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Osteoarthritis, Knee Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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One per day, Formula diet

The Cambridge Programme. Formula diet One-daily

Group Type ACTIVE_COMPARATOR

day formula diet

Intervention Type DIETARY_SUPPLEMENT

The Cambridge Programme. Formula diet

Repeated formula diet

Dietary instruction (low-energy diet) 3x5 weeks per year

Group Type EXPERIMENTAL

day formula diet

Intervention Type DIETARY_SUPPLEMENT

The Cambridge Programme. Formula diet

Interventions

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day formula diet

The Cambridge Programme. Formula diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Former participant in the CAROT study ( NCT00655941 )

\-

Exclusion Criteria

Bilateral knee alloplasty -
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Velux Fonden

OTHER

Sponsor Role collaborator

Oak Foundation

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Cambridge Weight Plan Limited

INDUSTRY

Sponsor Role collaborator

Henning Bliddal

OTHER

Sponsor Role lead

Responsible Party

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Henning Bliddal

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Denmark

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.

Reference Type BACKGROUND
PMID: 17204567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17038126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15639633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28747328 (View on PubMed)

Related Links

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http://www.parkerinst.dk

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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