Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study (LIGH T)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Long-term Intervention With Weight Loss in Patients With Concomitant Obesity and Knee Osteoarthritis. The LIGHT Study |
- Weight, number of patients operated with knee alloplasty [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Former participant in the CAROT study ( NCT00655941 )
-
Exclusion Criteria:
Bilateral knee alloplasty -
Contacts and Locations| Contact: Henning Bliddal, professor | +45 38164158 | parker@frh.regionh.dk |
| Contact: Birgit F Riecke, MD | +45 38164158 | parker@frh.regionh.dk |
| Denmark | |
| The Parker Institute, Frederiksberg Hospital | Recruiting |
| Frederiksberg, Denmark, 2000 | |
| Principal Investigator: Henning Bliddal, Professor | |
| Sub-Investigator: Birgit F Riecke, MD | |
| Principal Investigator: | Henning Bliddal, Professor | The P |
More 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 |
| Study First Received: | July 13, 2009 |
| Last Updated: | January 5, 2012 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on June 18, 2013