AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Denmark

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.

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 groups in NCT03664167
Study groupRoleWhat they receive
interventionExperimentalintensive 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.
controlNo interventionusual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bodyweight

    change in bodyweight (kg) from baseline to week 16 visit.

    Measured: 16 weeks

Secondary outcomes (14)
  1. Serum urate levels.

    change in serum urate (mg/dL) from baseline to week 16 visit.

    Measured: 16 weeks

  2. Serum urate levels

    proportion of participants maintaining serum urate levels <6mg/dL at visit week 8 and week 16

    Measured: 16 weeks

  3. Serum urate levels

    percentage reduction in serum urate(%) at final visit (week 16)

    Measured: 16 weeks

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. swollen joint count (SJC)

    chagne in swollen joint count (SJC) from baseline to week 16

    Measured: 16 weeks

  12. tender joint count (TJC)

    change in tender joint count (TJC) from baseline to week 16

    Measured: 16 weeks

  13. tophi:change in number of tophi from baseline to week 16

    change in number of tophi from baseline to week 16

    Measured: 16 weeks

  14. 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.

  1. First posted10 Sep 2018
  2. Study start1 Dec 2018
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2019

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in