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Completed

NCT Number: NCT00938808

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Former participant in the CAROT study ( NCT00655941 )

-

Exclusion criteria

Bilateral knee alloplasty -

Treatment and study plan

day formula diet

Dietary Supplement

The Cambridge Programme. Formula diet

Primary outcomes

  1. Weight, number of patients operated with knee alloplasty

    Time frame: 1 year, 3 years

Secondary outcomes

  1. MRI

    Time frame: 1 year, 3 years

  2. Gait analysis

    Time frame: 1 year, 3 years

  3. Ultrasound

    Time frame: 1 year, 3 years

  4. Collagen markers

    Time frame: 1 year, 3 years

  5. Metabolic syndrome

    Time frame: 1 year, 3 years

  6. KOOS

    Time frame: 1 year, 3 years

Sponsors and collaborators

Lead sponsor

Henning Bliddal

Other

Collaborators

  • Cambridge Weight Plan Limited
  • Oak Foundation
  • The Danish Rheumatism Association
  • Velux Fonden

Registry information

Acronym: LIGH T

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2009
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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