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

Not Applicable

Completed

• Conditions: Obesity; Osteoarthritis, Knee
• Interventions: Dietary Supplement: day formula diet

• Registration Number: NCT00938808
• Lead Sponsor: Henning Bliddal

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Former participant in the CAROT study ( NCT00655941 )

Exclusion Criteria

Bilateral knee alloplasty -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated formula diet	day formula diet	Dietary instruction (low-energy diet) 3x5 weeks per year
One per day, Formula diet	day formula diet	The Cambridge Programme. Formula diet One-daily

Primary Outcome Measures

Name	Time	Method
Weight, number of patients operated with knee alloplasty	1 year, 3 years

Secondary Outcome Measures

Name	Time	Method
Ultrasound	1 year, 3 years
Gait analysis	1 year, 3 years
MRI	1 year, 3 years
Collagen markers	1 year, 3 years
KOOS	1 year, 3 years
Metabolic syndrome	1 year, 3 years

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark