Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis
VIPsA
1 other identifier
interventional
90
1 country
4
Brief Summary
The study is an open intervention study with the aim to determine the effects of weight-loss treatment with Low-Energy liquid Diet (LED) on disease activity, quality of life and markers of the metabolic syndrome in patients with psoriatic arthritis and obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Apr 2016
Longer than P75 for not_applicable obesity
4 active sites
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
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2021
CompletedOctober 12, 2021
May 1, 2020
3.7 years
September 21, 2016
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Minimal Disease Activity (MDA) which is a composite outcome measure
5 of 7 of the following criteria: Tender joint count ≤ 1 Swollen joint count ≤ 1 PASI ≤ 1or BSA ≤ 3 Patient pain VAS ≤ 15 Patient global activity VAS ≤ 20 HAQ ≤ 0.5 Tender entheseal points ≤ 1 BSA: body surface area; HAQ: Health Assessment Questionnaire; PASI
6 months
Study Arms (2)
Patients with PsA and obesity
ACTIVE COMPARATORVery Low Energy Diet (VLED)
Patients with obesity
OTHERVery Low Energy Diet (VLED)
Interventions
Very Low Energy Diet (VLED), divided into 4 daily doses, gives any intake of 640 calories per day together with the recommended doses of vitamins and minerals. During an initial period of 12 weeks the patients only consume VLED. After the strict period food is successively reintroduced during a period of 18 weeks.
Eligibility Criteria
You may qualify if:
- PsA fulfilling the Classification for Psoriatic Arthritis (CASPAR) criteria
- BMI≥33 kg/m2
- Age 18-75 years
You may not qualify if:
- Pregnancy
- Porphyria
- Epilepsy
- Diabetes type 1
- Severe heart or kidney disease
- Eating disorder
- Severe catabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Rheumatology at the Hospital of Alingsås
Alingsås, 441 33, Sweden
Department of Rheumatology at the Hospital of Borås
Borås, 501 82, Sweden
Department of Obesity and Internal Medicine at Sahlgrenska University Hospital
Gothenburg, SE-41345, Sweden
Department of Rheumatology at Sahlgrenska University Hospital
Gothenburg, SE-41345, Sweden
Related Publications (6)
Torres L, Jonsson CA, Eliasson B, Forsblad-d'Elia H, Landgren AJ, Bilberg A, Gjertsson I, Larsson I, Klingberg E. A six-month weight loss intervention is associated with significant changes in serum biomarkers related to inflammation, bone and cartilage metabolism in obese patients with psoriatic arthritis and matched controls. BMC Rheumatol. 2025 May 23;9(1):58. doi: 10.1186/s41927-025-00511-0.
PMID: 40410839DERIVEDLandgren AJ, Bilberg A, Eliasson B, Torres L, Dehlin M, Jacobsson LTH, Larsson I, Klingberg E. Health-related quality of life significantly improved in obese patients with psoriatic arthritis one year after a structured weight loss intervention. Adv Rheumatol. 2025 Mar 14;65(1):13. doi: 10.1186/s42358-025-00444-9.
PMID: 40087727DERIVEDLandgren AJ, Jonsson CA, Bilberg A, Eliasson B, Torres L, Dehlin M, Jacobsson LTH, Gjertsson I, Larsson I, Klingberg E. Serum IL-23 significantly decreased in obese patients with psoriatic arthritis six months after a structured weight loss intervention. Arthritis Res Ther. 2023 Jul 27;25(1):131. doi: 10.1186/s13075-023-03105-8.
PMID: 37501212DERIVEDBilberg A, Larsson I, Bjorkman S, Eliasson B, Klingberg E. The impact of a structured weight-loss treatment on physical fitness in patients with psoriatic arthritis and obesity compared to matched controls: a prospective interventional study. Clin Rheumatol. 2022 Sep;41(9):2745-2754. doi: 10.1007/s10067-022-06164-5. Epub 2022 Jun 1.
PMID: 35648298DERIVEDKlingberg E, Bjorkman S, Eliasson B, Larsson I, Bilberg A. Weight loss is associated with sustained improvement of disease activity and cardiovascular risk factors in patients with psoriatic arthritis and obesity: a prospective intervention study with two years of follow-up. Arthritis Res Ther. 2020 Oct 22;22(1):254. doi: 10.1186/s13075-020-02350-5.
PMID: 33092646DERIVEDKlingberg E, Bilberg A, Bjorkman S, Hedberg M, Jacobsson L, Forsblad-d'Elia H, Carlsten H, Eliasson B, Larsson I. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019 Jan 11;21(1):17. doi: 10.1186/s13075-019-1810-5.
PMID: 30635024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Klingberg, M.D., Ph.D.
Department of Rheumatology and Inflammation Research, Sahlgrenska Academy at the University of Gothenburg, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2016
First Posted
September 28, 2016
Study Start
April 1, 2016
Primary Completion
December 12, 2019
Study Completion
October 6, 2021
Last Updated
October 12, 2021
Record last verified: 2020-05