ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02978001
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Filip Krag Knop, University Hospital, Gentofte, Copenhagen

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.


Condition or disease Intervention/treatment
Insulin Sensitivity Metabolism Disorder Other: Stabile Isotope tracers

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Insulin Sensitivity, Glucose - and Fat Metabolism in Patients With Psoriasis
Study Start Date : August 2016
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Psoriasis

Group/Cohort Intervention/treatment
Patients with Psoriasis
Patients with moderate to severe psoriasis (PASI>8)
Other: Stabile Isotope tracers
Non-radioactive tracers used in hyperinsulinaemic euglycaemic clamp
Other Name: [6,6-D2]glucose, [1,1,2,3,3,-D5]glycerol

Healthy Control Subjects
Healthy subjects matching the patients with psoriasis regarding age, gender and BMI
Other: Stabile Isotope tracers
Non-radioactive tracers used in hyperinsulinaemic euglycaemic clamp
Other Name: [6,6-D2]glucose, [1,1,2,3,3,-D5]glycerol




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 6 hours ]
    Experimental day 2


Secondary Outcome Measures :
  1. Non-oxidative glucose metabolism [ Time Frame: 6 hours ]
    Experimental day 2

  2. Endogenous glucose production [ Time Frame: 6 hours ]
    Experimental day 2

  3. Lipolysis [ Time Frame: 6 hours ]
    Experimental day 2

  4. glucose oxidation [ Time Frame: 6 hours ]
    Experimental day 2

  5. Fat oxidation [ Time Frame: 6 hours ]
    Experimental day 2

  6. Molecular changes in muscle and fat tissue [ Time Frame: 6 hours ]
    Experimental day 2

  7. Beta-cell secretion rate [ Time Frame: 1 hour ]
    Experimental day 1


Biospecimen Retention:   Samples With DNA
Muscle and fat biopsies. Blood samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Caucasian adults
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978001


Contacts
Contact: Nikolaj Ulrik Friis 0045 22947374 nufriis@gmail.com
Contact: Heidi Storgaard, cand.med., ph.d.

Locations
Denmark
Center for Diabetes Research, Gentofte Hospital, Denmark Recruiting
Hellerup, Copenhagen, Denmark, 2100
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

Responsible Party: Filip Krag Knop, Professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02978001     History of Changes
Other Study ID Numbers: MetPso
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Insulin Resistance
Psoriasis
Hypersensitivity
Metabolic Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs