The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover

Overview

The investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. Using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2020

Interventions

  • Drug: Betnovate, betamethasone dipropionate ointment 0.1% and placebo
    • Explore the systemic effects of Betnovate
  • Drug: Protopic, tacrolimus ointment 0.1%
    • Compare the systemic effects of Betnovate to Protopic

Arms, Groups and Cohorts

  • Experimental: Betamethasone-17-valerat + placebo ointment
    • Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing corticosteroid (“Betnovate”, betamethasone dipropionate ointment 0.1%) and placebo
  • Active Comparator: Tacrolimus ointment
    • Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor (“Protopic”, tacrolimus ointment 0.1%)

Clinical Trial Outcome Measures

Primary Measures

  • Change in whole-body insulin sensitivity
    • Time Frame: Baseline, after 14 days daily treatment, and after 4 weeks of twice daily treatment twice weekly
    • Change in whole-body insulin sensitivity during treatment with topical corticosteroid use compared to the control group treated with topical calcineurin inhibitors. Insulin sensitivity will be assessed by the hyperinsulinaemic euglycaemic clamp method with glucose and glycerol tracer and indirect calorimetry (rate of disappearance (Rd)).

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18-75 years
  • AD according to the Hanifin and Rajka Criteria24
  • AD for at least 3 years
  • BMI ≤ 30 kg/m2
  • Haemoglobin A1c (HbA1c) ≤ 42 mmol/mol (6.0%)
  • Normal haemoglobin (men: 8.3-10.5 mmol/L and women 7.3-9.5 mmol/L. A 5% deviation will be allowed if the patient besides this is healthy)
  • Informed consent
  • In general patients should not be diagnosed with diseases that may affect or be affected by the study/treatment (evaluated by a doctor) (such as untreated skin infections, acne vulgaris (beside face region), a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease, congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression, and Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. Further patients should not suffer from kidney or liver disease/insufficiency. See the SPC for Protopic and Betnovate.)

Exclusion Criteria

  • Diagnosed diabetes mellitus
  • Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
  • Pregnancy (a urine test will be done at every visit and birth control is required, see below*)
  • Breast feeding
  • Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
  • Daily smoker, alcoholic, or drug abuser
  • Hypersensitivity to Protopic or Betnovate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jacob Thyssen
  • Collaborator
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jacob Thyssen, Professor, consultant – University Hospital, Gentofte, Copenhagen
  • Overall Official(s)
    • Jacob P Thyssen, Professor, MD, DMSc, Principal Investigator, Department of Dermatology and Allergy, Gentofte Hospital, Denmark
  • Overall Contact(s)
    • Lise Gether, MD, +4591175147, lise.gether.01@regionh.dk

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