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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00938808
Acronym
LIGH T
Enrollment
154
Registered
2009-07-14
Start date
2009-06-30
Completion date
2013-12-31
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Osteoarthritis, Knee

Keywords

Osteoarthritis, Obesity, Weight loss, Dietary instruction, Formula diet, Attention

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.

Interventions

DIETARY_SUPPLEMENTday formula diet

The Cambridge Programme. Formula diet

Sponsors

Velux Fonden
CollaboratorOTHER
Oak Foundation
CollaboratorOTHER
The Danish Rheumatism Association
CollaboratorOTHER
Cambridge Weight Plan Limited
CollaboratorINDUSTRY
Henning Bliddal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Former participant in the CAROT study ( NCT00655941 ) \-

Exclusion criteria

Bilateral knee alloplasty -

Design outcomes

Primary

MeasureTime frame
Weight, number of patients operated with knee alloplasty1 year, 3 years

Secondary

MeasureTime frame
Gait analysis1 year, 3 years
Ultrasound1 year, 3 years
MRI1 year, 3 years
Metabolic syndrome1 year, 3 years
KOOS1 year, 3 years
Collagen markers1 year, 3 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026