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| Name | Class |
|---|---|
| Velux Fonden | OTHER |
| Oak Foundation | OTHER |
| The Danish Rheumatism Association | OTHER |
| Cambridge Weight Plan Limited |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One per day, Formula diet | Active Comparator | The Cambridge Programme. Formula diet One-daily |
|
| Repeated formula diet | Experimental | Dietary instruction (low-energy diet) 3x5 weeks per year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| day formula diet | Dietary Supplement | The Cambridge Programme. Formula diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight, number of patients operated with knee alloplasty | 1 year, 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| MRI | 1 year, 3 years | |
| Gait analysis | 1 year, 3 years | |
| Ultrasound |
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Inclusion Criteria:
Former participant in the CAROT study ( NCT00655941 )
-
Exclusion Criteria:
Bilateral knee alloplasty -
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| Name | Affiliation | Role |
|---|---|---|
| Henning Bliddal, Professor | The P | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute, Frederiksberg Hospital | Frederiksberg | Frederiksberg | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17204567 | Background | 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. | |
| 17038126 | Background | 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. |
| Label | URL |
|---|---|
| Web page of the Parker Institute, Frederiksberg Hospital, Denmark | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009765 | Obesity |
| D010003 | Osteoarthritis |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| INDUSTRY |
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| 1 year, 3 years |
| Collagen markers | 1 year, 3 years |
| Metabolic syndrome | 1 year, 3 years |
| KOOS | 1 year, 3 years |
| 15639633 | Background | 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. |
| 28747328 | Derived | 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. |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |