The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
Overview
- Phase
- Phase 4
- Intervention
- Betnovate, betamethasone dipropionate ointment 0.1% and placebo
- Conditions
- Atopic Dermatitis
- Sponsor
- Jacob Thyssen
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in whole-body insulin sensitivity
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Jacob Thyssen
Professor, consultant
University Hospital, Gentofte, Copenhagen
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Betnovate, betamethasone dipropionate ointment 0.1% and placebo
Tacrolimus ointment
Atopic dermatitis patients: topical treatment with twice daily full-body ointment containing calcineurin inhibitor ("Protopic", tacrolimus ointment 0.1%)
Intervention: Protopic, tacrolimus ointment 0.1%
Outcomes
Primary Outcomes
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)).