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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Frederiksberg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Health & Weight Plan, UK
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00938808
First received: July 13, 2009
Last updated: January 5, 2012
Last verified: January 2012

July 13, 2009
January 5, 2012
June 2009
December 2013   (final data collection date for primary outcome measure)
Weight, number of patients operated with knee alloplasty [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00938808 on ClinicalTrials.gov Archive Site
  • MRI [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
  • Gait analysis [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
  • Ultrasound [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
  • Collagen markers [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
  • Metabolic syndrome [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
  • KOOS [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Obesity
Dietary Supplement: day formula diet
The Cambridge Programme. Formula diet
  • Active Comparator: One per day, Formula diet
    The Cambridge Programme. Formula diet One-daily
    Intervention: Dietary Supplement: day formula diet
  • Experimental: Repeated formula diet
    Dietary instruction (low-energy diet) 3x5 weeks per year
    Intervention: Dietary Supplement: day formula diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Former participant in the CAROT study ( NCT00655941 )

-

Exclusion Criteria:

Bilateral knee alloplasty -

Both
50 Years and older
No
Contact: Henning Bliddal, professor +45 38164158 parker@frh.regionh.dk
Contact: Birgit F Riecke, MD +45 38164158 parker@frh.regionh.dk
Denmark
 
NCT00938808
H-B-2009-029
No
Henning Bliddal, Frederiksberg University Hospital
Henning Bliddal
  • Velux Fonden
  • Oak Foundation
  • The Danish Rheumatism Association
  • Cambridge Health & Weight Plan, UK
Principal Investigator: Henning Bliddal, Professor The P
Frederiksberg University Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP