NCT03664167

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

September 7, 2018

Last Update Submit

June 20, 2021

Conditions

Gout, Arthritis, Obesity

Keywords

goutObesityarthritis

Outcome Measures

Primary Outcomes (1)

  • Bodyweight

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

    16 weeks

Secondary Outcomes (14)

  • Serum urate levels.

    16 weeks

  • Serum urate levels

    16 weeks

  • Serum urate levels

    16 weeks

  • Flare: the proportion of individuals with any gout flare in the FIRST 8 weeks following randomisation]

    8 weeks

  • Flare:the proportion of individuals with any gout flare in the LAST 8 weeks following randomisation

    16 weeks

  • +9 more secondary outcomes

Study Arms (2)

intervention

EXPERIMENTAL

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.

control

NO INTERVENTION

usual care

Interventions

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.

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, the Parker Institute, Frederiksberg and Bispebjerg Hospital

Frederiksberg, Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

GoutArthritisObesity

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lars Erik Kristensen, MD

    CSO The Parker Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 10, 2018

Study Start

December 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

DK(1)