Glucocorticoids ToxicityFUSIONNCT06145126
Effects of Glucocortioids in Human Skeletal Muscle, Adipose Tissue and Skin
A study testing Prednisolone in people with Glucocorticoids Toxicity and Iatrogenic Effect, run by University of Aarhus.
Trial 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 hypothesized to mediate this process. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucocorticoids Toxicity, Iatrogenic Effect
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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 hypothesized to mediate this process.
AIM: Utilizing human data, the investigators study the effects of GC exposure on skeletal muscle structure and function, adipose tissue and skin in healthy older subjects.
Read more
METHODS: FAPs will be analyzed in biopsies from skeletal muscles, adipose tissue and skin and further characterized using scRNA-sequencing and Fluorescence-Activated Cell Sorting. Body composition including muscle mass (DXA scan), muscle strength, spontaneous physical activity and glucose homeostasis are recorded.
PERSPECTIVES: The investigators combine translational research with multidisciplinary and international collaboration to elucidate the pathophysiology of GC excess, which is of significant clinical interest since 3% of the Danish population receive GC treatment.
Read the 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 years. This age group is close to that of patients receiving short-term, high dose anti-inflammatory prednisolone treatment and thus provides a bridge between a clinically observered problem. The participants will be randomized to receive either prednisolone (37,5mg/d) or placebo treatment for five consecutive days. In addition to muscle, skin, and adipose tissue biopsies and body composition measurement (DXA), each participant will undergo the following measurements before and after the intervention: spontaneous physical activity (actigraphy), ambulatory 24-hour blood pressure, continuous glucose monitoring (CGM), pulse wave velocity (PWV), and muscle strength. Each participant is studied before and after the 5-day treatment period.
Outcomes:
- FAPs expression in skeletal muscle and adipose tissue:
- Fluorescence Activated Cell Sorting (FACS) mediated quantification, isolation and transcriptomic profiling at population and single-cell level of FAPs, and immunological cells
- Time-to-first division of isolation FAPs
- In vitro fibro- and adipogenic differentiation of FAPs
- Single cell transcriptome analysis (scRNA-seq) to profile cell types in a hypothesis-generating perspective.
- Functional outcomes: Muscle mass and strength (DXA scan and isometric quadriceps strength) and spontaneous physical activity (actigraphy)
- Metabolic outcomes: circadian blood glucose and blood pressure, and basal insulin sensitivity.
- Conditions
- Glucocorticoids Toxicity, Iatrogenic Effect
- Being tested
- Prednisolone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneOther
Predisolone is used as a tool to elicit a physiological response (toolbox trial) and not as a pharmaceutical agent/treatment.
PlaceboOther
Placebo to predinisolon
| Study group | Role | What they receive |
|---|---|---|
| Start pred/End placebo | Other | Both arms will receive both placebo and prednisone Receives: Other: Prednisolone; Other: Placebo |
| Start placebo/End pred | Other | Both arms will receive both placebo and prednisone Receives: Other: Prednisolone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAPs expression in skeletal muscle, adipose tissue, and skin
Single cell transcriptome analysis (scRNA-seq) to profile cell types in a hypothesis-generating perspective.
Measured: 2 Years
Secondary outcomes (6)
Dual X-ray scan (DXA)
Bodycomposition (grams)
Measured: 2 Years
Metabolic outcomes - Circadian blood glucose
Blood monitoring using Dexcom censor (unit: mmol/L)
Measured: Years
Dynamometer
Isometric muscle contraction (power)
Measured: 2 Years
24h blood pressure
Systolic and diastolic (mmHg)
Measured: 2 Years
Basal insulin sensitivity.
Blood samples (pmol/L)
Measured: 2 Years
Activity level
Spontanous activity level using a wrist ban monitor (ActiGraph)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoids ToxicityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, randomized, crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145126
- Sponsor's protocol ID
- FUSION
- Acronym
- FUSION
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucocortioids in Human Skeletal Muscle, Adipose Tissue and Skin
- ClinicalTrials.gov ID
- NCT06145126
- Acronym / sponsor ID
- FUSION / FUSION
- Conditions
- Glucocorticoids Toxicity, Iatrogenic Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 hypothesized to mediate this process.
AIM: Utilizing human data, the investigators study the effects of GC exposure on skeletal muscle structure and function, adipose tissue and skin in healthy older subjects.
METHODS: FAPs will be analyzed in biopsies from skeletal muscles, adipose tissue and skin and further characterized using scRNA-sequencing and Fluorescence-Activated Cell Sorting. Body composition including muscle mass (DXA scan), muscle strength, spontaneous physical activity and glucose homeostasis are recorded.
PERSPECTIVES: The investigators combine translational research with multidisciplinary and international collaboration to elucidate the pathophysiology of GC excess, which is of significant clinical interest since 3% of the Danish population receive GC treatment.
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 years. This age group is close to that of patients receiving short-term, high dose anti-inflammatory prednisolone treatment and thus provides a bridge between a clinically observered problem. The participants will be randomized to receive either prednisolone (37,5mg/d) or placebo treatment for five consecutive days. In addition to muscle, skin, and adipose tissue biopsies and body composition measurement (DXA), each participant will undergo the following measurements before and after the intervention: spontaneous physical activity (actigraphy), ambulatory 24-hour blood pressure, continuous glucose monitoring (CGM), pulse wave velocity (PWV), and muscle strength. Each participant is studied before and after the 5-day treatment period.
Outcomes:
- FAPs expression in skeletal muscle and adipose tissue:
- Fluorescence Activated Cell Sorting (FACS) mediated quantification, isolation and transcriptomic profiling at population and single-cell level of FAPs, and immunological cells
- Time-to-first division of isolation FAPs
- In vitro fibro- and adipogenic differentiation of FAPs
- Single cell transcriptome analysis (scRNA-seq) to profile cell types in a hypothesis-generating perspective.
- Functional outcomes: Muscle mass and strength (DXA scan and isometric quadriceps strength) and spontaneous physical activity (actigraphy)
- Metabolic outcomes: circadian blood glucose and blood pressure, and basal insulin sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled, randomized, crossover
| Arm | Type | Receives |
|---|---|---|
| Start pred/End placebo | Other | Other: Prednisolone, Other: PlaceboBoth arms will receive both placebo and prednisone |
| Start placebo/End pred | Other | Other: Prednisolone, Other: PlaceboBoth arms will receive both placebo and prednisone |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisolonePredisolone is used as a tool to elicit a physiological response (toolbox trial) and not as a pharmaceutical agent/treatment. | Other | Start placebo/End pred, Start pred/End placebo |
| PlaceboPlacebo to predinisolon | Other | Start placebo/End pred, Start pred/End placebo |
Primary outcome
FAPs expression in skeletal muscle, adipose tissue, and skin
Time frame: 2 Years
Single cell transcriptome analysis (scRNA-seq) to profile cell types in a hypothesis-generating perspective.
6 secondary outcomes
Dual X-ray scan (DXA)
Time frame: 2 Years
Metabolic outcomes - Circadian blood glucose
Time frame: Years
Dynamometer
Time frame: 2 Years
24h blood pressure
Time frame: 2 Years
Basal insulin sensitivity.
Time frame: 2 Years
Activity level
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone in people with Glucocorticoids Toxicity and Iatrogenic Effect, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAPs expression in skeletal muscle, adipose tissue, and skin (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.