Incretin Effect in Patients With Psoriasis and Controls

Incretin Effect in Patients With Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Diagnostic test: Oral glucose tolerance test; Other: Intravenous isoglycaemic glucose clamp; Other: Liquid Mixed meal test

• Study Type: Observational
• Enrollment (Actual): 24

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psoriasis	Diagnostic test: Oral glucose tolerance test; Oral glucose tolerance test 50g; Other: Intravenous isoglycaemic glucose clamp; Intravenous isoglycaemic glucose clamp; Other: Liquid Mixed meal test; Liquid Mixed meal test 520 kcal
Control; Age, Sex and BMI matched	Diagnostic test: Oral glucose tolerance test; Oral glucose tolerance test 50g; Other: Intravenous isoglycaemic glucose clamp; Intravenous isoglycaemic glucose clamp; Other: Liquid Mixed meal test; Liquid Mixed meal test 520 kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity measures	Matsudas insulin sensitivity index: (10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT))	0-180 minutes
Concentration of Glucose-independent insulinotropic polypeptide	Evaluted as Area Under the Curve	0-180 minutes
Concentration of Glucagon-like peptide 1	Evaluated as Area Under the Curve	0-180 minuntes
Concentration of Glucagon	Evaluated as Area Under the Curve	0-180 minutes
Concentration of Insulin	Evaluated as Area Under the Curve	0-180 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2011
• Primary Completion (Actual): September 11, 2015
• Study Completion (Actual): September 11, 2015

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 11031999

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No