Incretin Effect in Patients With Psoriasis and Controls

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT06064084
• Collaborator: (none)
• Enrollment: 24
• Actual Duration (Months): 48

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Diagnostic Test: Oral glucose tolerance test; Other: Intravenous isoglycaemic glucose clamp; Other: Liquid Mixed meal test

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Incretin Effect in Patients With Psoriasis
• Actual Study Start Date: Sep 11, 2011
• Actual Primary Completion Date: Sep 11, 2015
• Actual Study Completion Date: Sep 11, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incretin effect measured with Beta-cell secretory response [0-180 minutes]

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

Secondary Outcome Measures

1. Insulin sensitivity measures [0-180 minutes]

   Matsudas insulin sensitivity index: (10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT))

2. Concentration of Glucose-independent insulinotropic polypeptide [0-180 minutes]

   Evaluted as Area Under the Curve

3. Concentration of Glucagon-like peptide 1 [0-180 minuntes]

   Evaluated as Area Under the Curve

4. Concentration of Glucagon [0-180 minutes]

   Evaluated as Area Under the Curve

5. Concentration of Insulin [0-180 minutes]

   Evaluated as Area Under the Curve

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Filip Krag Knop, Professor, MD, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT06064084
• Other Study ID Numbers: 11031999
• First Posted: Oct 3, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Oct 3, 2023