NCT06064084

Brief Summary

To investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 11, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2015

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

September 14, 2023

Last Update Submit

September 28, 2023

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Incretin effect measured with Beta-cell secretory response

    Incretineffect (%) = 100 % × (Beta-cell Secretory Response (OGTT) - Beta-cell Secretory Response (IIGI)) / Beta-cell Secretory Response (OGTT)

    0-180 minutes

Secondary Outcomes (5)

  • Insulin sensitivity measures

    0-180 minutes

  • Concentration of Glucose-independent insulinotropic polypeptide

    0-180 minutes

  • Concentration of Glucagon-like peptide 1

    0-180 minuntes

  • Concentration of Glucagon

    0-180 minutes

  • Concentration of Insulin

    0-180 minutes

Study Arms (2)

Psoriasis

Diagnostic Test: Oral glucose tolerance testOther: Intravenous isoglycaemic glucose clampOther: Liquid Mixed meal test

Control

Age, Sex and BMI matched

Diagnostic Test: Oral glucose tolerance testOther: Intravenous isoglycaemic glucose clampOther: Liquid Mixed meal test

Interventions

Oral glucose tolerance testDIAGNOSTIC_TEST

Oral glucose tolerance test 50g

ControlPsoriasis
Intravenous isoglycaemic glucose clampOTHER

Intravenous isoglycaemic glucose clamp

ControlPsoriasis
Liquid Mixed meal testOTHER

Liquid Mixed meal test 520 kcal

ControlPsoriasis

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases with psoriasis vulgaris (PASI\>8) Controls with no existing skin disease. Matched for Age, BMI and Sex

You may qualify if:

  • no diabetes BMI \< 27 kg/m\^2 normal Glucose tolerance test at screening normal fasting plasma glucose no islet auto antibodies no hormonel contraception informed consent psoriasis vulgaris (PASI\>8) (case not controls)

You may not qualify if:

  • other chronic inflammtory skin disease other chronic inflammatory disease pregnancy psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lauritsen JV, Bergmann N, Junker AE, Gyldenlove M, Skov L, Gluud LL, Hartmann B, Holst JJ, Vilsboll T, Knop FK. Oral glucose has little or no effect on appetite and satiety sensations despite a significant gastrointestinal response. Eur J Endocrinol. 2023 Dec 6;189(6):619-626. doi: 10.1093/ejendo/lvad161.

    PMID: 38035766DERIVED

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

September 14, 2023

First Posted

October 3, 2023

Study Start

September 11, 2011

Primary Completion

September 11, 2015

Study Completion

September 11, 2015

Last Updated

October 3, 2023

Record last verified: 2023-09