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
  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

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Weight, number of patients operated with knee alloplasty [ Time Frame: 1 year, 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

Former participant in the CAROT study ( NCT00655941 )

-

Exclusion Criteria:

Bilateral knee alloplasty -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938808

Contacts
Contact: Henning Bliddal, professor +45 38164158 parker@frh.regionh.dk
Contact: Birgit F Riecke, MD +45 38164158 parker@frh.regionh.dk

Locations
Denmark
The Parker Institute, Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, 2000
Principal Investigator: Henning Bliddal, Professor         
Sub-Investigator: Birgit F Riecke, MD         
Sponsors and Collaborators
Henning Bliddal
Velux Fonden
Oak Foundation
The Danish Rheumatism Association
Cambridge Health & Weight Plan, UK
Investigators
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 July 28, 2014