Gout, Arthritis, ObesityNCT03664167
Weight Loss for Obese Individuals With Gout
A study testing intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician. in people with Gout, Arthritis, Obesity, run by Henning Bliddal at 1 site in Denmark.
Trial summary
This study evaluates effect of weight loss in a group of obese patients with gouty arthritis. The study is a randomised group trial where half the patients receive intensive weight loss in the form of meal replacement from Cambridge as well as supervision from a clinical dietician and the other half get usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Arthritis, Obesity
- What is being tested?
- intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2018to 1 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of gouty arthritis per expert opinion and the ACR/EULAR 2015 criteria for gout.
- have had at least one self-reported flare in the last 12 months
- BMI >30kg/m2
- >18 years of age
Who cannot join
- pregnant
- hisotry or suspicion of drug abuse within the past 5 years
- Active muscle disease, cancer, previous kidney disease, and/or fatty liver
- An estimated creatinine clearance <30 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
- An investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
- Any other medical or psychological condition which, in the opinion of the investigator and/or medical monitor, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements, or to complete the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Rheumatology, the Parker Institute, Frederiksberg and Bispebjerg Hospital
Frederiksberg, Copenhagen, 2000
About this study
Official title: Weight Loss as Treatment for Gout in Patients With Concomitant Obesity: Protocol for a Proof-of-concept Randomised, Non-blinded, Parallel-group Trial
This study evaluates effect of weight loss in a group of obese patients with gouty arthritis. The study is a randomised group trial where half the patients receive intensive weight loss in the form of meal replacement from Cambridge as well as supervision from a clinical dietician and the other half get usual care.
Read the detailed description
Background Gout is an increasingly common disorder characterised by elevated serum urate (SU) and by acute and chronic arthritis causing severe disability and pain. Long-term management of gout focuses on urate-lowering therapy (ULT), and keeping SU under its solubility threshold. When SU is kept under the threshold for solubility, the frequency of gout flares will decrease and the urate crystals dispositioned in the joints will dissolve. New therapeutic management of gout has in recent years emerged. However, despite the potential for effective treatment, gout management remains suboptimal.
there is some physiological evidence, although sparse, that weight loss in patients with gout reduces both SU and number of gout flares. Despite the scarcity of data regarding the effects of weight loss in gout, international guidelines recommend dietary intervention and weight loss as a core management strategy in patients with concomitant gout and obesity The aim with the current study is to address whether or not there is a difference in success rate in weight reduction, SU levels, and possible side-effects between the 2 approaches in the "short-term", by comparing a weight loss group to an ongoing no-treatment (usual care) group.
recruitment Participants will be recruited from the out-patient clinics at the Parker Institute, Bispebjerg and Frederiksberg Hospital and the Department of Rheumatology, Herlev-Gentofte Hospital, Denmark, through advertisements in newspapers and on the website of the Parker Institute. Additionally, local general practitioners will be informed about the possibility to assign patients to the project. All participants will be pre-screened via telephone using a series of standard questions about eligibility according to criteria of inclusion and exclusion. This study aims at being as pragmatic and inclusive as possible with few exclusion criteria
Interventions All the participants who sign informed consent will be randomly assigned to either 16 (8+8) weeks of low-energy diet (LED; 3.4 MJ/day; i.e., the Intensive Diet [ID] group) OR a corresponding 16-week conventional hypo-energetic, high protein diet (app. 5 MJ/day) defined as a control group (i.e., conventional diet [CD] group).
Intensive Diet (ID) Group: The first phase of the study consists of an 8-week weight reduction programme where the participants initiate an LED diet-only, with 3.4 MJ/day (810 kcal per day) in a supervised dietary programme (products provided by The Cambridge Weight Plan). They will be given nutritional and dietetic instructions by an experienced dietitian in sessions of 1-2 h weekly.
The second phase (ID Group) of the study (week 8-16), will consist of an 8 weeks' fixed energy diet programme using 5 MJ/day (1,200 kcal per day) incorporating two diet products daily. The principles of the diet will be in line with the current guidelines for healthy eating issued by the Danish National Board of Health, i.e. low-fat, low-sugar and high-fibre.
Conventional Diet (CD) Group: The programme will consist of a presentation by the same dietitian as for the ID group, who will provide nutritional advice in a 2 h session at baseline (week 0), and in week 8. At these sessions the dietitian will recommend eating ordinary foods in amounts which will provide the patients with approximately 5 MJ/day (1,200 kcal per day). The follow-up meeting at week 16 will not influence the outcome. Thus, during the 16 week trial, the CD group will attend three sessions altogether with a total of approximately 4h of instruction.
- Conditions
- Gout, Arthritis, Obesity
- Being tested
- intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.
- Keywords
- gout, Obesity, arthritis
- Medical subject headings
- Gout, Arthritis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.Dietary supplement
intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician. Receives: Dietary Supplement: intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician. |
| control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bodyweight
change in bodyweight (kg) from baseline to week 16 visit.
Measured: 16 weeks
Secondary outcomes (14)
Serum urate levels.
change in serum urate (mg/dL) from baseline to week 16 visit.
Measured: 16 weeks
Serum urate levels
proportion of participants maintaining serum urate levels <6mg/dL at visit week 8 and week 16
Measured: 16 weeks
Serum urate levels
percentage reduction in serum urate(%) at final visit (week 16)
Measured: 16 weeks
Flare: the proportion of individuals with any gout flare in the FIRST 8 weeks following randomisation]
the proportion of individuals with any gout flare in the FIRST 8 weeks following randomisation
Measured: 8 weeks
Flare:the proportion of individuals with any gout flare in the LAST 8 weeks following randomisation
the proportion of individuals with any gout flare in the LAST 8 weeks following randomisation
Measured: 16 weeks
Flare:the number of gout flares during the trial period for each patient
the number of gout flares during the trial period for each patient
Measured: 16 weeks
functional status - measured by the "Health Assessment Questionaire" (HAQ).
change in functional status (HAQ) from baseline to week 16. HAQ consists of 20 questions on disability. The score ranges from 0-3. 0 being without problems and 3 with severe disability. the total score is an average of all questions.
Measured: 16 weeks
pain from their gout - measured on a visual analoge scale (VAS)
change in pain from their gout (VAS) from baseline to week 16. Ranges from 0-100mm on a VAS. 0mm being no pain, 100mm being the worst possible pain.
Measured: 16 weeks
patient global - measured on a visual analoge scale (VAS)
change in patient global (VAS) from baseline to week 16. Ranges from 0-100mm on a VAS. 0mm being best possible health. 100mm being the worst possible health.
Measured: 16 weeks
fatigue - measured on a visual analoge scale(VAS)
change in fatigue (VAS) from baseline to week 16. Ranges from 0-100mm on a VAS. 0mm being no fatigue. 100mm being worst possible fatigue imagined by the patient.
Measured: 16 weeks
swollen joint count (SJC)
chagne in swollen joint count (SJC) from baseline to week 16
Measured: 16 weeks
tender joint count (TJC)
change in tender joint count (TJC) from baseline to week 16
Measured: 16 weeks
tophi:change in number of tophi from baseline to week 16
change in number of tophi from baseline to week 16
Measured: 16 weeks
SF-36
change in 36-Item Short Form Health Survey (SF-36: MCS and PCS apply) from baseline to week 16.
there is included 8 subscales which combine into two overall domains - a physical combined score (PCS) and a mental combined score (MCS). The scales ranges from 0- 100. where 0 is maximum disability and 100 is no disability.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Dec 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gout, Arthritis, ObesityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Bliddal
- Sponsor type
- University, hospital or other
- Collaborators
- Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
- Responsible party
- Sponsor-investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Lars Erik Kristensen, MD, Principal investigator, CSO The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664167
- Sponsor's protocol ID
- 140
- Status last verified
- Jun 2021
- First submitted
- 7 Sep 2018
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christensen R, Zobbe K, Nielsen SM, Stamp LK, Henriksen M, Overgaard AF, Dreyer L, Knop FK, Singh JA, Doherty M, Richette P, Astrup A, Ellegaard K, Bartels EM, Boesen M, Gudbergsen H, Bliddal H, Kristensen LE. Weight Loss for Patients With Gout and Concomitant Obesity: A Proof-of-Concept Randomized Trial. Arthritis Rheumatol. 2024 May;76(5):806-812. doi: 10.1002/art.42790. Epub 2024 Feb 20.
PubMed 38169151
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss as Treatment for Gout in Patients With Concomitant Obesity: Protocol for a Proof-of-concept Randomised, Non-blinded, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT03664167
- Acronym / sponsor ID
- 140
- Conditions
- Gout, Arthritis, Obesity
- Keywords
- gout, Obesity, arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Henning BliddalUniversity, hospital or other
- Collaborators
- Oak Foundation, The Danish Rheumatism Association, Cambridge Weight Plan Limited
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- 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.
This study evaluates effect of weight loss in a group of obese patients with gouty arthritis. The study is a randomised group trial where half the patients receive intensive weight loss in the form of meal replacement from Cambridge as well as supervision from a clinical dietician and the other half get usual care.
Detailed description
Background Gout is an increasingly common disorder characterised by elevated serum urate (SU) and by acute and chronic arthritis causing severe disability and pain. Long-term management of gout focuses on urate-lowering therapy (ULT), and keeping SU under its solubility threshold. When SU is kept under the threshold for solubility, the frequency of gout flares will decrease and the urate crystals dispositioned in the joints will dissolve. New therapeutic management of gout has in recent years emerged. However, despite the potential for effective treatment, gout management remains suboptimal.
there is some physiological evidence, although sparse, that weight loss in patients with gout reduces both SU and number of gout flares. Despite the scarcity of data regarding the effects of weight loss in gout, international guidelines recommend dietary intervention and weight loss as a core management strategy in patients with concomitant gout and obesity The aim with the current study is to address whether or not there is a difference in success rate in weight reduction, SU levels, and possible side-effects between the 2 approaches in the "short-term", by comparing a weight loss group to an ongoing no-treatment (usual care) group.
recruitment Participants will be recruited from the out-patient clinics at the Parker Institute, Bispebjerg and Frederiksberg Hospital and the Department of Rheumatology, Herlev-Gentofte Hospital, Denmark, through advertisements in newspapers and on the website of the Parker Institute. Additionally, local general practitioners will be informed about the possibility to assign patients to the project. All participants will be pre-screened via telephone using a series of standard questions about eligibility according to criteria of inclusion and exclusion. This study aims at being as pragmatic and inclusive as possible with few exclusion criteria
Interventions All the participants who sign informed consent will be randomly assigned to either 16 (8+8) weeks of low-energy diet (LED; 3.4 MJ/day; i.e., the Intensive Diet [ID] group) OR a corresponding 16-week conventional hypo-energetic, high protein diet (app. 5 MJ/day) defined as a control group (i.e., conventional diet [CD] group).
Intensive Diet (ID) Group: The first phase of the study consists of an 8-week weight reduction programme where the participants initiate an LED diet-only, with 3.4 MJ/day (810 kcal per day) in a supervised dietary programme (products provided by The Cambridge Weight Plan). They will be given nutritional and dietetic instructions by an experienced dietitian in sessions of 1-2 h weekly.
The second phase (ID Group) of the study (week 8-16), will consist of an 8 weeks' fixed energy diet programme using 5 MJ/day (1,200 kcal per day) incorporating two diet products daily. The principles of the diet will be in line with the current guidelines for healthy eating issued by the Danish National Board of Health, i.e. low-fat, low-sugar and high-fibre.
Conventional Diet (CD) Group: The programme will consist of a presentation by the same dietitian as for the ID group, who will provide nutritional advice in a 2 h session at baseline (week 0), and in week 8. At these sessions the dietitian will recommend eating ordinary foods in amounts which will provide the patients with approximately 5 MJ/day (1,200 kcal per day). The follow-up meeting at week 16 will not influence the outcome. Thus, during the 16 week trial, the CD group will attend three sessions altogether with a total of approximately 4h of instruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Dietary Supplement: intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician. |
| control | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of gouty arthritis per expert opinion and the ACR/EULAR 2015 criteria for gout.
- have had at least one self-reported flare in the last 12 months
- BMI >30kg/m2
- >18 years of age
Key exclusion criteria (6 listed)
- pregnant
- hisotry or suspicion of drug abuse within the past 5 years
- Active muscle disease, cancer, previous kidney disease, and/or fatty liver
- An estimated creatinine clearance <30 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
- An investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
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 |
|---|---|---|
| intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician. | Dietary supplement | intervention |
Primary outcome
Bodyweight
Time frame: 16 weeks
change in bodyweight (kg) from baseline to week 16 visit.
14 secondary outcomes
Serum urate levels.
Time frame: 16 weeks
Serum urate levels
Time frame: 16 weeks
Serum urate levels
Time frame: 16 weeks
Flare: the proportion of individuals with any gout flare in the FIRST 8 weeks following randomisation]
Time frame: 8 weeks
Flare:the proportion of individuals with any gout flare in the LAST 8 weeks following randomisation
Time frame: 16 weeks
Flare:the number of gout flares during the trial period for each patient
Time frame: 16 weeks
functional status - measured by the "Health Assessment Questionaire" (HAQ).
Time frame: 16 weeks
pain from their gout - measured on a visual analoge scale (VAS)
Time frame: 16 weeks
patient global - measured on a visual analoge scale (VAS)
Time frame: 16 weeks
fatigue - measured on a visual analoge scale(VAS)
Time frame: 16 weeks
swollen joint count (SJC)
Time frame: 16 weeks
tender joint count (TJC)
Time frame: 16 weeks
tophi:change in number of tophi from baseline to week 16
Time frame: 16 weeks
SF-36
Time frame: 16 weeks
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 24 Jun 2021.
- Derived from this study: PubMed 38169151Christensen R, Zobbe K, Nielsen SM, Stamp LK, Henriksen M, Overgaard AF, Dreyer L, Knop FK, Singh JA, Doherty M, Richette P, Astrup A, Ellegaard K, Bartels EM, Boesen M, Gudbergsen H, Bliddal H, Kristensen LE. Weight Loss for Patients With Gout and Concomitant Obesity: A Proof-of-Concept Randomized Trial. Arthritis Rheumatol. 2024 May;76(5):806-812. doi: 10.1002/art.42790. Epub 2024 Feb 20.
- 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.
Lars Erik Kristensen, MD principal investigator
CSO The Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician. in people with Gout, Arthritis, Obesity, run by Henning Bliddal at 1 site in Denmark.
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 4 inclusion and 6 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Bodyweight (time frame: 16 weeks). 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 NCT03664167, which also lists 1 linked publication.
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 24 Jun 2021.