Status:

UNKNOWN

Effects of Glucocortioids in Human Skeletal Muscle, Adipose Tissue and Skin

Lead Sponsor:

University of Aarhus

Conditions:

Glucocorticoids Toxicity

Iatrogenic Effect

Eligibility:

All Genders

55+ years

Phase:

NA

Brief Summary

BACKGROUND: A notorious and dreaded adverse effect of glucocorticoids (GC) is redistribution of muscle and fat mass towards muscle wasting and visceral obesity. Fibroadipogenic progenitors (FAPs) are ...

Detailed Description

Design: randomized, double blind, placebo-controlled trial. The aim is to study the effect of short-term GC exposure on skeletal muscle, skin , adipose tissue in 12 healthy adults above the age of 50 ...

Eligibility Criteria

Inclusion

  • Written and oral consent prior to study beginning
  • Age of or above 50 years
  • Healthy (uncomplicated hypertension and hypercholesteroleamia is accepted)
  • BMI of or below 35

Exclusion

  • Consumption of glucocorticoid pharmaceuticals (inhalation steroids, intra-articular or intra-muscular injections, steroid creme group IV-V used in the genital area). Allowed pharmaceuticals: ocular drops, nasal sprays/drops, steroid creme group I-III, steroid creme group IV-V used in non-genital areas
  • Alcohol consumption of more than 21 units per week
  • Consumption of strong CYP3A4 inhibitors/inducers
  • Serious comorbidity (heart, liver, or kidney failure, as well as cooncurrent cancer/chemotherapy treatment)
  • High daily activity level (more than 30min per day or more than 2 organized workouts per week)

Key Trial Info

Start Date :

December 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2025

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT06145126

Start Date

December 1 2023

End Date

July 1 2025

Last Update

November 22 2023

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