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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938808
First Posted: July 14, 2009
Last Update Posted: January 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Weight Plan Limited
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee Obesity Dietary Supplement: day formula diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study

Resource links provided by NLM:


Further study details as provided by Henning Bliddal, Frederiksberg University Hospital:

Primary Outcome Measures:
  • Weight, number of patients operated with knee alloplasty [ Time Frame: 1 year, 3 years ]

Secondary Outcome Measures:
  • MRI [ Time Frame: 1 year, 3 years ]
  • Gait analysis [ Time Frame: 1 year, 3 years ]
  • Ultrasound [ Time Frame: 1 year, 3 years ]
  • Collagen markers [ Time Frame: 1 year, 3 years ]
  • Metabolic syndrome [ Time Frame: 1 year, 3 years ]
  • KOOS [ Time Frame: 1 year, 3 years ]

Enrollment: 154
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One per day, Formula diet
The Cambridge Programme. Formula diet One-daily
Dietary Supplement: day formula diet
The Cambridge Programme. Formula diet
Experimental: Repeated formula diet
Dietary instruction (low-energy diet) 3x5 weeks per year
Dietary Supplement: day formula diet
The Cambridge Programme. Formula diet

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Former participant in the CAROT study ( NCT00655941 )

Exclusion Criteria:

Bilateral knee alloplasty -

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938808


Locations
Denmark
The Parker Institute, Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Henning Bliddal
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Weight Plan Limited
Investigators
Principal Investigator: Henning Bliddal, Professor The P
  More Information

Additional Information:
Publications:
Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00938808     History of Changes
Other Study ID Numbers: H-B-2009-029
First Submitted: July 13, 2009
First Posted: July 14, 2009
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by Henning Bliddal, Frederiksberg University Hospital:
Osteoarthritis
Obesity
Weight loss
Dietary instruction
Formula diet
Attention

Additional relevant MeSH terms:
Obesity
Osteoarthritis
Weight Loss
Osteoarthritis, Knee
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes