ObesityVIPsANCT02917434
Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis
A study testing Very Low Energy Diet (VLED) in people with Obesity and Psoriatic Arthritis, run by Vastra Gotaland Region at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Psoriatic Arthritis, Metabolic Syndrome
- What is being tested?
- Very Low Energy Diet (VLED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesSweden
- Study dates
- Apr 2016to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PsA fulfilling the Classification for Psoriatic Arthritis (CASPAR) criteria
- BMI≥33 kg/m2
- Age 18-75 years
Who cannot join
- Pregnancy
- Porphyria
- Epilepsy
- Diabetes type 1
- Severe heart or kidney disease
- Eating disorder
- Severe catabolic disease
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Department of Rheumatology at the Hospital of Alingsås
Alingsås, 441 33
Department of Rheumatology at the Hospital of Borås
Borås, 501 82
Department of Obesity and Internal Medicine at Sahlgrenska University Hospital
Gothenburg, SE-41345
Department of Rheumatology at Sahlgrenska University Hospital
Gothenburg, SE-41345
About this study
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.
Read the detailed description
BACKGROUND Psoriasis is a common skin disease affecting around 2-3% of the population in Sweden. Approximately 20-30% of the individuals with psoriasis develop psoriatic arthritis (PsA). PsA mainly engage the musculoskeletal apparatus and causes inflammation of joints, tendons and ligaments, but the disease also increases the risk of developing anterior uveitis and inflammatory bowel disease, especially Crohn's disease.
Both psoriasis and PsA are strongly associated with obesity and the metabolic syndrome (Mets). Observational studies have reported a frequency of obesity (body mass index; BMI≥30 kg/m2) in 45% and of MetS in 30-45% of PsA patients. Earlier studies have shown that obesity increases the risk of developing both psoriasis and PsA and that obesity is associated with increased disease activity, poorer treatment response and lower chance of achieving minimal disease activity.
Although the association between PsA and obesity is well known, there are only a small number of interventional studies which have assessed the effects of weight loss on disease activity in PsA.
Patients with PsA also have an increased risk of cardiovascular disease. [12, 13] Chronic inflammation, which accelerates the atherosclerotic process, in combination with a higher prevalence of cardiovascular risk factors among PsA patients is believed to contribute to this increased risk.
Obesity causes a low grade systemic inflammation via the production of pro-inflammatory mediators in the white adipose tissue, such as adipokines and cytokines (e.g. tumour necrosis factor-α and interleukin-6), which are also involved in the pathogenic process if PsA. Obesity-related inflammation could thus act synergistically with autoimmune inflammation in the development and the maintenance of disease in psoriasis and PsA.
Weight-loss treatment with Very Low Energy Diet (VLED) is an effective and approved method in clinical use in Sweden. In severe obesity, BMI 35 kg/m2 or more, a strict energy restriction is needed for optimal weight-loss. The LED gives a daily intake of 640 calories together with the recommended doses of vitamins and minerals. During an initial period of 12 weeks the patients only consume LED. The weight-loss with this intake is 1-2 kilograms per weeks. After the strict period food is successively reintroduced during a period of 18 weeks. The treatment is given within the framework of a structured program including support and medical follow-up from a team of doctors, nurses and dieticians.
AIMS The aims of this study are
- To determine the effects of weight loss treatment on disease activity, function, quality of life and markers for the metabolic syndrome in patients with psoriatic arthritis
- To study the specific effects on the immune system of the negative energy balance during the strict energy restriction period and prospectively, during a two year follow-up
- To investigate if there are differences in body-composition, markers for Mets and adipokines between patients with PsA and obesity and controls with obesity before during and after weight loss treatment.
PATIENTS AND METHODS Patients with PsA and obesity registered at the Rheumatology clinics of Sahlgrenska University hospital and the hospitals of Alingsås and Borås are invited to participate.
The results of the PsA patients will be compared with control patients with obesity (PsA or psoriasis) matched for age, sex and BMI who undergo the same weight loss treatment with VLED.
Disease activity, physical function and quality of life will be assessed by physical examination (including anthropometric measures, joints, tendons, back mobility and skin) and by validated questionnaires at baseline (start of weight-loss treatment), 3 months, 6 months, 12 months and 24 months. Blood samples will be collected at the same appointments.
Body-composition will be measured at baseline and 12 months. Muscle strengths and physical function will be measured at baseline, 6 months and 12 months and physical activity will be assessed with questionnaires and accelerometers.
Informed written consent will be obtained from all patients and controls. The study was approved by the local regional ethics committee in Gothenburg and will be carried out in accordance with the Helsinki Declaration.
- Being tested
- Very Low Energy Diet (VLED)
- Keywords
- Obesity, Psoriatic arthritis, Psoriasis, Metabolic syndrome, Cardiovascular disease
- Medical subject headings
- Obesity, Arthritis, Psoriatic, Metabolic Syndrome, Psoriasis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Energy Diet (VLED)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PsA and obesity | Active comparator | Very Low Energy Diet (VLED) Receives: Dietary Supplement: Very Low Energy Diet (VLED) |
| Patients with obesity | Other | Very Low Energy Diet (VLED) Receives: Dietary Supplement: Very Low Energy Diet (VLED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startApr 2016
- Primary completion12 Dec 2019
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eva Klingberg, M.D., Ph.D., Principal investigator, Department of Rheumatology and Inflammation Research, Sahlgrenska Academy at the University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917434
- Sponsor's protocol ID
- 211861
- Acronym
- VIPsA
- Status last verified
- May 2020
- First submitted
- 21 Sep 2016
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40410839Landgren 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.
PubMed 40087727Landgren 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.
PubMed 37501212Bilberg 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.
PubMed 35648298Klingberg 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.
PubMed 33092646Klingberg 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.
PubMed 30635024
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT02917434
- Acronym / sponsor ID
- VIPsA / 211861
- Keywords
- Obesity, Psoriatic arthritis, Psoriasis, Metabolic syndrome, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Apr 2016
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Psoriasis is a common skin disease affecting around 2-3% of the population in Sweden. Approximately 20-30% of the individuals with psoriasis develop psoriatic arthritis (PsA). PsA mainly engage the musculoskeletal apparatus and causes inflammation of joints, tendons and ligaments, but the disease also increases the risk of developing anterior uveitis and inflammatory bowel disease, especially Crohn's disease.
Both psoriasis and PsA are strongly associated with obesity and the metabolic syndrome (Mets). Observational studies have reported a frequency of obesity (body mass index; BMI≥30 kg/m2) in 45% and of MetS in 30-45% of PsA patients. Earlier studies have shown that obesity increases the risk of developing both psoriasis and PsA and that obesity is associated with increased disease activity, poorer treatment response and lower chance of achieving minimal disease activity.
Although the association between PsA and obesity is well known, there are only a small number of interventional studies which have assessed the effects of weight loss on disease activity in PsA.
Patients with PsA also have an increased risk of cardiovascular disease. [12, 13] Chronic inflammation, which accelerates the atherosclerotic process, in combination with a higher prevalence of cardiovascular risk factors among PsA patients is believed to contribute to this increased risk.
Obesity causes a low grade systemic inflammation via the production of pro-inflammatory mediators in the white adipose tissue, such as adipokines and cytokines (e.g. tumour necrosis factor-α and interleukin-6), which are also involved in the pathogenic process if PsA. Obesity-related inflammation could thus act synergistically with autoimmune inflammation in the development and the maintenance of disease in psoriasis and PsA.
Weight-loss treatment with Very Low Energy Diet (VLED) is an effective and approved method in clinical use in Sweden. In severe obesity, BMI 35 kg/m2 or more, a strict energy restriction is needed for optimal weight-loss. The LED gives a daily intake of 640 calories together with the recommended doses of vitamins and minerals. During an initial period of 12 weeks the patients only consume LED. The weight-loss with this intake is 1-2 kilograms per weeks. After the strict period food is successively reintroduced during a period of 18 weeks. The treatment is given within the framework of a structured program including support and medical follow-up from a team of doctors, nurses and dieticians.
AIMS The aims of this study are
- To determine the effects of weight loss treatment on disease activity, function, quality of life and markers for the metabolic syndrome in patients with psoriatic arthritis
- To study the specific effects on the immune system of the negative energy balance during the strict energy restriction period and prospectively, during a two year follow-up
- To investigate if there are differences in body-composition, markers for Mets and adipokines between patients with PsA and obesity and controls with obesity before during and after weight loss treatment.
PATIENTS AND METHODS Patients with PsA and obesity registered at the Rheumatology clinics of Sahlgrenska University hospital and the hospitals of Alingsås and Borås are invited to participate.
The results of the PsA patients will be compared with control patients with obesity (PsA or psoriasis) matched for age, sex and BMI who undergo the same weight loss treatment with VLED.
Disease activity, physical function and quality of life will be assessed by physical examination (including anthropometric measures, joints, tendons, back mobility and skin) and by validated questionnaires at baseline (start of weight-loss treatment), 3 months, 6 months, 12 months and 24 months. Blood samples will be collected at the same appointments.
Body-composition will be measured at baseline and 12 months. Muscle strengths and physical function will be measured at baseline, 6 months and 12 months and physical activity will be assessed with questionnaires and accelerometers.
Informed written consent will be obtained from all patients and controls. The study was approved by the local regional ethics committee in Gothenburg and will be carried out in accordance with the Helsinki Declaration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with PsA and obesity | Active comparator | Dietary Supplement: Very Low Energy Diet (VLED)Very Low Energy Diet (VLED) |
| Patients with obesity | Other | Dietary Supplement: Very Low Energy Diet (VLED)Very Low Energy Diet (VLED) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PsA fulfilling the Classification for Psoriatic Arthritis (CASPAR) criteria
- BMI≥33 kg/m2
- Age 18-75 years
Key exclusion criteria (7 listed)
- Pregnancy
- Porphyria
- Epilepsy
- Diabetes type 1
- Severe heart or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Energy Diet (VLED)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. | Dietary supplement | Patients with PsA and obesity, Patients with obesity |
Primary outcome
Minimal Disease Activity (MDA) which is a composite outcome measure
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 40410839Torres 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.
- Derived from this study: PubMed 40087727Landgren 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.
- Derived from this study: PubMed 37501212Landgren 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.
- Derived from this study: PubMed 35648298Bilberg 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.
- Derived from this study: PubMed 33092646Klingberg 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.
- Derived from this study: PubMed 30635024Klingberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Klingberg, M.D., Ph.D. principal investigator
Department of Rheumatology and Inflammation Research, Sahlgrenska Academy at the University of Gothenburg, Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Energy Diet (VLED) in people with Obesity and Psoriatic Arthritis, run by Vastra Gotaland Region at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Disease Activity (MDA) which is a composite outcome measure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917434, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.