Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study (LIGH T)
Primary Purpose
Osteoarthritis, Knee, Obesity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
day formula diet
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Obesity, Weight loss, Dietary instruction, Formula diet, Attention
Eligibility Criteria
Inclusion Criteria:
Former participant in the CAROT study ( NCT00655941 )
-
Exclusion Criteria:
Bilateral knee alloplasty -
Sites / Locations
- The Parker Institute, Frederiksberg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
One per day, Formula diet
Repeated formula diet
Arm Description
The Cambridge Programme. Formula diet One-daily
Dietary instruction (low-energy diet) 3x5 weeks per year
Outcomes
Primary Outcome Measures
Weight, number of patients operated with knee alloplasty
Secondary Outcome Measures
MRI
Gait analysis
Ultrasound
Collagen markers
Metabolic syndrome
KOOS
Full Information
NCT ID
NCT00938808
First Posted
July 13, 2009
Last Updated
January 15, 2016
Sponsor
Henning Bliddal
Collaborators
Velux Fonden, Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
1. Study Identification
Unique Protocol Identification Number
NCT00938808
Brief Title
Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
Acronym
LIGH T
Official Title
Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henning Bliddal
Collaborators
Velux Fonden, Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Obesity
Keywords
Osteoarthritis, Obesity, Weight loss, Dietary instruction, Formula diet, Attention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One per day, Formula diet
Arm Type
Active Comparator
Arm Description
The Cambridge Programme. Formula diet One-daily
Arm Title
Repeated formula diet
Arm Type
Experimental
Arm Description
Dietary instruction (low-energy diet) 3x5 weeks per year
Intervention Type
Dietary Supplement
Intervention Name(s)
day formula diet
Intervention Description
The Cambridge Programme. Formula diet
Primary Outcome Measure Information:
Title
Weight, number of patients operated with knee alloplasty
Time Frame
1 year, 3 years
Secondary Outcome Measure Information:
Title
MRI
Time Frame
1 year, 3 years
Title
Gait analysis
Time Frame
1 year, 3 years
Title
Ultrasound
Time Frame
1 year, 3 years
Title
Collagen markers
Time Frame
1 year, 3 years
Title
Metabolic syndrome
Time Frame
1 year, 3 years
Title
KOOS
Time Frame
1 year, 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Former participant in the CAROT study ( NCT00655941 )
-
Exclusion Criteria:
Bilateral knee alloplasty -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Bliddal, Professor
Organizational Affiliation
The P
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
17204567
Citation
Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.
Results Reference
background
PubMed Identifier
17038126
Citation
Bliddal H, Christensen R. The management of osteoarthritis in the obese patient: practical considerations and guidelines for therapy. Obes Rev. 2006 Nov;7(4):323-31. doi: 10.1111/j.1467-789X.2006.00252.x.
Results Reference
background
PubMed Identifier
15639633
Citation
Christensen R, Astrup A, Bliddal H. Weight loss: the treatment of choice for knee osteoarthritis? A randomized trial. Osteoarthritis Cartilage. 2005 Jan;13(1):20-7. doi: 10.1016/j.joca.2004.10.008.
Results Reference
background
PubMed Identifier
28747328
Citation
Christensen P, Henriksen M, Bartels EM, Leeds AR, Meinert Larsen T, Gudbergsen H, Riecke BF, Astrup A, Heitmann BL, Boesen M, Christensen R, Bliddal H. Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial. Am J Clin Nutr. 2017 Sep;106(3):755-763. doi: 10.3945/ajcn.117.158543. Epub 2017 Jul 26.
Results Reference
derived
Links:
URL
http://www.parkerinst.dk
Description
Web page of the Parker Institute, Frederiksberg Hospital, Denmark
Learn more about this trial
Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study
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