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Completed

NCT Number: NCT04114097

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology and Allergy

Hellerup, Capital Region, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betnovate, betamethasone dipropionate ointment 0.1% and placebo

Drug

Explore the systemic effects of Betnovate

Protopic, tacrolimus ointment 0.1%

Drug

Compare the systemic effects of Betnovate to Protopic

Primary outcomes

  1. 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)).

Sponsors and collaborators

Lead sponsor

Jacob Thyssen

Other

Collaborators

  • LEO Pharma

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2019
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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