PsoriasisNCT01137188
Effect of Weight Loss on Psoriasis
A study testing Low calorie diet in people with Psoriasis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. No controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Low calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Sep 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive therapy
- BMI > 27
Who cannot join
- pregnancy/breast feeding
- diabetes requiring insulin treatment
- severe heart/kidney/liver disease
- gout
- high potassium intake
- obesity due to medical conditions/medications
Show all 9Show fewer
- use of medical treatment for obesity
- previous bariatric surgery
- intentional/unintentional weight loss up to 3 months prior to inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital Gentofte, Department of Dermato-venerology
Hellerup, 2900
About this study
Official title: Effect of Weight Loss on Skin Manifestations, Inflammatory Markers and Risk Factor for Comorbidity in Obese Patients With Psoriasis - a Randomized Cross-over Study
Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. No controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting.
Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic comorbidities such as arterial hypertension, coronary vascular disease, stroke, hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of early death. Lately the role of inflammation in the atherosclerotic process has been highlighted and the link between psoriasis and atherosclerosis may be explained by the concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation is seen in obesity where macrophages and adipocytes begin to show overlap in function and gene expression. This leads to an increased migration of macrophages into the adipose tissue and an increased secretion of pro-inflammatory cytokines. In summary, these data and theoretical considerations suggest that weight loss in obese patients with psoriasis may improve skin manifestations and reduce the risk of atherosclerotic comorbidity.
- Conditions
- Psoriasis
- Being tested
- Low calorie diet
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low calorie dietDietary supplement
Low calorie diet containing 800-1000 kcal/day
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intensive weight loss program and regular group sessions with clinical dietician. Complete dietary substitution with a low calorie diet containing 800-1000 kcal/day for 8 weeks Receives: Dietary Supplement: Low calorie diet |
| No intervention | No intervention | Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI
Psoriasis area and severity index
Measured: Baseline
PASI
Psoriasis area severity index
Measured: 4 weeks
PASI
Psoriasis area severity index
Measured: 8 weeks
PASI
Psoriasis area severity index
Measured: 12 weeks
PASI
Psoriasis area severity index
Measured: 16 weeks
Secondary outcomes (5)
Risk factors for comorbidity
Risk factors for comorbidity
Measured: Baseline
Risk factors for comorbidity
Risk factors for comorbidity
Measured: 4 weeks
Risk factors for comorbidity
Risk factors for comorbidity
Measured: 8 weeks
Risk factors for comorbidity
Risk factors for comorbidity
Measured: 12 weeks
Risk factors for comorbidity
Risk factors for comorbidity
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 posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Peter Jensen, University Hospital, Gentofte, Copenhagen
- Investigators
- Lone Skov, MD, phd, Principal investigator, Copenhagen University Hospital Gentofte, Department of Dermato-venerology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137188
- Sponsor's protocol ID
- H-2-2010-001
- Status last verified
- Apr 2012
- First submitted
- 18 Mar 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen P, Christensen R, Zachariae C, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Long-term effects of weight reduction on the severity of psoriasis in a cohort derived from a randomized trial: a prospective observational follow-up study. Am J Clin Nutr. 2016 Aug;104(2):259-65. doi: 10.3945/ajcn.115.125849. Epub 2016 Jun 22.
PubMed 27334236Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Astrup A, Hansen PR, Skov L. Effect of weight loss on the cardiovascular risk profile of obese patients with psoriasis. Acta Derm Venereol. 2014 Nov;94(6):691-4. doi: 10.2340/00015555-1824.
PubMed 24556829Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Effect of weight loss on the severity of psoriasis: a randomized clinical study. JAMA Dermatol. 2013 Jul;149(7):795-801. doi: 10.1001/jamadermatol.2013.722.
PubMed 23752669
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Skin Manifestations, Inflammatory Markers and Risk Factor for Comorbidity in Obese Patients With Psoriasis - a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT01137188
- Acronym / sponsor ID
- H-2-2010-001
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Jun 2010 (estimated)
- 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.
Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. No controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting.
Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic comorbidities such as arterial hypertension, coronary vascular disease, stroke, hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of early death. Lately the role of inflammation in the atherosclerotic process has been highlighted and the link between psoriasis and atherosclerosis may be explained by the concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation is seen in obesity where macrophages and adipocytes begin to show overlap in function and gene expression. This leads to an increased migration of macrophages into the adipose tissue and an increased secretion of pro-inflammatory cytokines. In summary, these data and theoretical considerations suggest that weight loss in obese patients with psoriasis may improve skin manifestations and reduce the risk of atherosclerotic comorbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Low calorie dietIntensive weight loss program and regular group sessions with clinical dietician. Complete dietary substitution with a low calorie diet containing 800-1000 kcal/day for 8 weeks |
| No intervention | No intervention | –Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive therapy
- BMI > 27
Key exclusion criteria (9 listed)
- pregnancy/breast feeding
- diabetes requiring insulin treatment
- severe heart/kidney/liver disease
- gout
- high potassium intake
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 |
|---|---|---|
| Low calorie dietLow calorie diet containing 800-1000 kcal/day | Dietary supplement | Intervention group |
Primary outcome
PASI
Time frame: Baseline
Psoriasis area and severity index
PASI
Time frame: 4 weeks
Psoriasis area severity index
PASI
Time frame: 8 weeks
Psoriasis area severity index
PASI
Time frame: 12 weeks
Psoriasis area severity index
PASI
Time frame: 16 weeks
Psoriasis area severity index
5 secondary outcomes
Risk factors for comorbidity
Time frame: Baseline
Risk factors for comorbidity
Time frame: 4 weeks
Risk factors for comorbidity
Time frame: 8 weeks
Risk factors for comorbidity
Time frame: 12 weeks
Risk factors for comorbidity
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 4 Apr 2012.
- Derived from this study: PubMed 27334236Jensen P, Christensen R, Zachariae C, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Long-term effects of weight reduction on the severity of psoriasis in a cohort derived from a randomized trial: a prospective observational follow-up study. Am J Clin Nutr. 2016 Aug;104(2):259-65. doi: 10.3945/ajcn.115.125849. Epub 2016 Jun 22.
- Derived from this study: PubMed 24556829Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Astrup A, Hansen PR, Skov L. Effect of weight loss on the cardiovascular risk profile of obese patients with psoriasis. Acta Derm Venereol. 2014 Nov;94(6):691-4. doi: 10.2340/00015555-1824.
- Derived from this study: PubMed 23752669Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Effect of weight loss on the severity of psoriasis: a randomized clinical study. JAMA Dermatol. 2013 Jul;149(7):795-801. doi: 10.1001/jamadermatol.2013.722.
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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.
Lone Skov, MD, phd principal investigator
Copenhagen University Hospital Gentofte, Department of Dermato-venerology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low calorie diet in people with Psoriasis, run by University Hospital, Gentofte, Copenhagen 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 2 inclusion and 9 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 4 Apr 2012. 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?
PASI (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT01137188, which also lists 3 linked publications.
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 4 Apr 2012.