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Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis (VIPsA)

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ClinicalTrials.gov Identifier: NCT02917434
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

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.

Condition or disease Intervention/treatment Phase
Obesity Psoriatic Arthritis Metabolic Syndrome Psoriasis Cardiovascular Disease Dietary Supplement: Low Energy liquid Diet (LED) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Patients with PsA and obesity
Low Energy liquid Diet (LED)
Dietary Supplement: Low Energy liquid Diet (LED)
Low Energy liquid Diet (LED), divided into 4 daily doses, gives any intake of 880 calories per day together with the recommended doses of vitamins and minerals. During an initial period of 12 weeks the patients only consume LED. After the strict period food is successively reintroduced during a period of 18 weeks.

Patients with obesity
Low Energy liquid Diet (LED)
Dietary Supplement: Low Energy liquid Diet (LED)
Low Energy liquid Diet (LED), divided into 4 daily doses, gives any intake of 880 calories per day together with the recommended doses of vitamins and minerals. During an initial period of 12 weeks the patients only consume LED. After the strict period food is successively reintroduced during a period of 18 weeks.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PsA fulfilling the Classification for Psoriatic Arthritis (CASPAR) criteria
  • BMI≥33 kg/m2
  • Age 18-75 years

Exclusion Criteria:

  • Pregnancy
  • Porphyria
  • Epilepsy
  • Diabetes type 1
  • Severe heart or kidney disease
  • Eating disorder
  • Severe catabolic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917434


Locations
Sweden
Department of Rheumatology at the Hospital of Alingsås
Alingsås, Sweden, 441 33
Department of Rheumatology at the Hospital of Borås
Borås, Sweden, 501 82
Department of Obesity and Internal Medicine at Sahlgrenska University Hospital
Gothenburg, Sweden, SE-41345
Department of Rheumatology at Sahlgrenska University Hospital
Gothenburg, Sweden, SE-41345
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
Principal Investigator: Eva Klingberg, M.D., Ph.D. Department of Rheumatology and Inflammation Research, Sahlgrenska Academy at the University of Gothenburg, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02917434     History of Changes
Other Study ID Numbers: 211861
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Vastra Gotaland Region:
Obesity
Psoriatic arthritis
Psoriasis
Metabolic syndrome
Cardiovascular disease

Additional relevant MeSH terms:
Arthritis
Cardiovascular Diseases
Psoriasis
Weight Loss
Metabolic Syndrome X
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases