gewrichtsaandoeningen: jicht en metabool syndroom/hart- en vaatziekten gout
Conditions
Interventions
Personal counselling on a WFPD, based on the 3 hours of dietetic counselling
eligible for reimbursement by the Dutch National Health Insurance. Counselling
is divided into an introduction session of
Sponsors
Reade
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis of gout confirmed by a rheumatologist (first or recurrent episode) based on the ACR criteria (Neogi et al, 2015). Hyperuricemia (* * 7 mg/dL (0.42 mmol/L) and * * 6 mg/dL (0.36 mmol/L)) (Duskin-Bitan et al., 2014). Waist circumference of * * 102 cm and * * 88 cm.
Exclusion criteria
Exclusion criteria: - Concurrent presence of other forms of inflammatory joint disease than gout. - Intractable gout due to side effects or contra-indications for standard flare treatment (NSAIDs, colchicine and corticosteroids). - Current use of urate lowering therapy or use of urate lowering therapy in the last 30 days. - Indication for urate lowering therapy according national guidelines (NVR gout 2013) including 2 or more flares in one year, tophaceous gout or history of urate urolithiasis. Unless agreement between patient and treating rheumatologist led to the decision to postpone the start of ULT for the duration of at least the first 4 months of the study. - Pregnancy. - Insufficient comprehension of Dutch language. - Already following a (near-)vegan diet. - In case of smoking, unwillingness to stop smoking for at least the duration of the study. - Low e-health competencies (lowest proficiency according to Pharos quick scan) - Inability to be scheduled for counselling and measurement visits. - Psychiatric disease. - No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for the RCT study is the difference in mean change in serum uric acid levels between intervention- and control groups. The primary outcome for the extension study is the within-subject mean change in serum uric acid levels from 0-16 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gout disease activity: - Number of gout flares during the study. The definition of a gout flare is according to the patient (3 out of 4 criteria must be present): patient-defined gout flare, pain at rest>3 on a 0-10 point numerical rating scale, at least 1 swollen joint, at least 1 warm joint (Gaffo et al., 2018). - Mean duration of gout flares in days - Flare intensity measured with Visual Analogue Scale for pain (VAS 0-10) - Gout specific functioning and health will be measured using the validated Dutch Gout Assessment Questionnaire (GAQ2.0) (Spaetgens et al., 2014). - Use of gout flare medication including pain relief medication, NSAID*s, COXIBs, colchicine and corticosteroids (duration, dose, area under the curve (AUC)). Cardiovascular risk score and risk factors: - 10-years risk for fatal CVD (composite endpoint of age, gender, systolic blood pressure, cholesterol ratio and smoking status) (Conroy et al., 2003). - Arterial stiffness (as measured with the surrogate markers IMT and PWV). - Blood pressure - Body mass index - Waist circumference - Lipid profile: total cholesterol, LDL, HDL, triglycerides - Fasting plasma glucose - Hb1ac WFPD diet adherence: - adherence to a WFPD from 0-12 months | — |
Countries
Netherlands
Outcome results
None listed