Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02917434 |
| Other study ID # |
211861 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2016 |
| Est. completion date |
October 6, 2021 |
Study information
| Verified date |
May 2020 |
| Source |
Vastra Gotaland Region |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
