Insulin Sensitivity, Glucose - and Fat Metabolism in Patients With Psoriasis

NCT02978001 | Completed DMC

• 1 other identifier: MetPso
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The pathophysiological mechanisms explaining the association between psoriasis and type 2 diabetes are largely unknown but it has been hypothesized that systemic inflammation found in both psoriasis and type 2 diabetes might play a role. In a recent study hyperinsulinaemic euglycaemic clamps were performed and it showed that normal glucose-tolerant patients with moderate to severe psoriasis had lower whole-body insulin sensitivity during insulin stimulation compared to healthy matched controls. Thus, the increased risk of type 2 diabetes in patients with psoriasis appears to include defects in the glucose metabolism linked to psoriasis itself. However, the methods applied did not allow a detailed characterization of the metabolism in patients with psoriasis. Tracer technique combined with indirect calorimetry has never been applied to study hepatic and whole body insulin sensitivity, and glucose and fat oxidation, during basal conditions or during insulin stimulation in patients with psoriasis. Aim of study: The aim of this study is to investigate hepatic and whole body insulin sensitivity and glucose and fat oxidation during both basal and insulin-stimulated conditions in patients with psoriasis.

Conditions

Insulin Sensitivity; Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Experimental day 2

  6 hours

Secondary Outcomes (7)

• Non-oxidative glucose metabolism

  6 hours

• Endogenous glucose production

  6 hours

• Lipolysis

  6 hours

• glucose oxidation

  6 hours

• Fat oxidation

  6 hours

Study Arms (2)

Patients with Psoriasis

Patients with moderate to severe psoriasis (PASI\>8)

Other: Stabile Isotope tracers

Healthy Control Subjects

Healthy subjects matching the patients with psoriasis regarding age, gender and BMI

Other: Stabile Isotope tracers

Interventions

Stabile Isotope tracers OTHER

Non-radioactive tracers used in hyperinsulinaemic euglycaemic clamp

Also known as: [6,6-D2]glucose, [1,1,2,3,3,-D5]glycerol

Healthy Control Subjects; Patients with Psoriasis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caucasian adults

You may qualify if:

• Moderate to severe plaque psoriasis with psoriasis area and severity index (PASI) \>8 (exclusively for the patient group)
• Normal fasting plasma glucose (FPG) below 6 mM and haemoglobin A1c (HbA1c) ≤42 mmol/mol(6.0%)
• Normal haemoglobin
• Informed consent

You may not qualify if:

• Diabetes (type 1 and type 2 diabetes)
• First degree relatives with diabetes
• Other chronic inflammatory diseases
• Pregnancy or breast feeding
• Psychiatric diseases
• Treatment with drugs that might affect the glucose metabolism within a month prior to the project
• Nephropathy (serum creatinine \>130 µM and/or albuminuria)
• Liver disease (alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) \>2×normal values)

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Diabetes Research, Gentofte Hospital, Denmark

Hellerup, Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Muscle and fat biopsies. Blood samples.

MeSH Terms

Conditions

Insulin Resistance; Metabolic Diseases

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2016
• First Posted: November 30, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)