NCT00938808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

4.5 years

First QC Date

July 13, 2009

Last Update Submit

January 15, 2016

Conditions

Osteoarthritis, KneeObesity

Keywords

OsteoarthritisObesityWeight lossDietary instructionFormula dietAttention

Outcome Measures

Primary Outcomes (1)

  • Weight, number of patients operated with knee alloplasty

    1 year, 3 years

Secondary Outcomes (6)

  • MRI

    1 year, 3 years

  • Gait analysis

    1 year, 3 years

  • Ultrasound

    1 year, 3 years

  • Collagen markers

    1 year, 3 years

  • Metabolic syndrome

    1 year, 3 years

  • +1 more secondary outcomes

Study Arms (2)

One per day, Formula diet

ACTIVE COMPARATOR

The Cambridge Programme. Formula diet One-daily

Dietary Supplement: day formula diet

Repeated formula diet

EXPERIMENTAL

Dietary instruction (low-energy diet) 3x5 weeks per year

Dietary Supplement: day formula diet

Interventions

day formula dietDIETARY_SUPPLEMENT

The Cambridge Programme. Formula diet

One per day, Formula dietRepeated formula diet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Former participant in the CAROT study ( NCT00655941 )

You may not qualify if:

  • Bilateral knee alloplasty -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Frederiksberg, Frederiksberg, 2000, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 17204567BACKGROUND

  • 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.

    PMID: 17038126BACKGROUND

  • 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.

    PMID: 15639633BACKGROUND

  • 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.

    PMID: 28747328DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeObesityOsteoarthritisWeight Loss

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Henning Bliddal, Professor

    The P

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

DK(1)