To investigate the effect of a dietary intervention based on a WFPD on serum uric acid levels, gout disease activity and cardiovascular risk in patients with gout.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gewrichtsaandoeningen: jicht en metabool syndroom/hart- en vaatziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
An unhealthy diet is an important modifiable risk factor for hyperuricemia and
gout. Unhealthy diet is also associated with obesity and metabolic syndrome
(MetS), known risk factors for gout as well as for cardiovascular disease
(CVD). The prevalence of CVD is considerably elevated in patients with gout.
Current treatment of gout mainly consists of medication and advice to lower
alcohol consumption and avoid foods high in purine. Non-pharmacological
therapies for gout, such as dietary interventions, have not yet been
extensively studied. However, available evidence suggests that a
Mediterranean-style diet could be the most suitable long-term dietary strategy
for gout patients. A Mediterranean-style whole food plant-based diet (WFPD),
that has been shown to be effective for the treatment of other metabolic
syndrome- and obesity-related diseases (CVD and diabetes type 2), has not yet
been studied in patients with gout.
Study objective
To investigate the effect of a dietary intervention based on a WFPD on serum
uric acid levels, gout disease activity and cardiovascular risk in patients
with gout.
Study design
A 4-month randomized controlled trial (RCT), comparing a dietary intervention
with usual care in patients with gout (n=30). The control group will receive
the intervention after 4 months. After completion of the dietary intervention,
all patients will be followed in a one-year extension study.
Intervention
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 60 minutes and four sessions of 30
minutes after 2, 4, 8 and 12 weeks. The control group receives usual care.
During the one-year extension program subjects have 2 additional counselling
sessions of 30 minutes.
Study burden and risks
Participation includes 5 individual counselling sessions with a registered
dietitian in the RCT phase, followed by two additional individual counselling
sessions in the 12-months extension period. Subjects will undergo 3 measurement
visits in the course of the RCT (or 5 if starting in the control group) and 2
measurement visits during the 12-month extension period. Blood sampling will
stay below 80 ml per measurement and includes stored serum. Measurements
include: questionnaires, physical exam and blood samples at all measurement
visits and ultrasound at three (T0, T2 and T4) measurement visits.
Given the nature of the intervention, there is no risk associated with
participation, since the trial concerns healthy behavior. Subjects are
motivated patients and they may see the intervention as an opportunity rather
than a burden. Nonetheless, the intervention may be experienced as difficult or
tough. All patients will receive the intervention, either directly or after a
waiting list period.
Patients with an indication for urate-lowering therapy (ULT) at baseline will
not be included in this study unless shared decision making between patient and
rheumatologist leads to the decision to postpone the start of ULT until after
the RCT (if still necessary). This could give a delay of 4 months with possibly
avoidable gout attacks and joint damage, although the period of delay is short.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74142.029.20 |