HealthyNCT03866512
Forearm Immobilization, Metabolic Health, and Muscle Loss
A study testing Forearm immobilization in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The present study will investigate the impact of altered substrate availability on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Forearm immobilization
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18-40 years of age
- Body mass index between 18 and 27
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
- Any diagnosed cardiovascular disease
- Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
- Regular use of nutritional supplements
- Metallic implants
Show all 17Show fewer
- A personal or family history of thrombosis, epilepsy, seizures or schizophrenia
- Any previous motor disorders
- Any known disorders in lipid metabolism
- Any known disorders in muscle metabolism
- Known allergy for Acipimox, beta agonist, or other substances in the tablets
- Known sensitivity for sympathomimetic drugs
- Known hypokalaemia
- Presence of an ulcer in the stomach or gut and/or strong history of indigestion
- Known severe kidney problems
- Pregnancy
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Exeter & Devon NHS Foundation Trust
Exeter, Devon
About this study
Official title: The Impact of Acipimox and Salbutamol Supplementation on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers
The present study will investigate the impact of altered substrate availability on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization
Read the detailed description
Thirty-six healthy young volunteers will undergo 2 days of forearm immobilization combined with ingestion of one of two drug or placebo. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.
- Conditions
- Healthy
- Being tested
- Forearm immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm immobilizationBehavioural
Two days of forearm immobilization
| Study group | Role | What they receive |
|---|---|---|
| Acipimox ingestion during immobilization | Experimental | Oral ingestion of Acipimox during 2 days of forearm immobilization Receives: Behavioral: Forearm immobilization |
| B-agonist during immobilization | Experimental | Oral ingestion of salbutamol during 2 days of forearm immobilization Receives: Behavioral: Forearm immobilization |
| Placebo ingestion during immobilization | Placebo comparator | Oral ingestion of a placebo 2 days of forearm immobilization Receives: Behavioral: Forearm immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Forearm Glucose Uptake
Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions
Measured: During the steady-state phase of the insulin clamp (i.e. last 30 min)
Secondary outcomes (1)
Percent Change in Muscle Protein Synthesis
Percent change in muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion
Measured: In the fasted state (30 min before starting insulin clamp), and during the steady-state phase of the insulin clamp (i.e. last 30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start10 May 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Marlou Dirks, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866512
- Sponsor's protocol ID
- 250839
- Other IDs
- 209198/Z/17/Z
- Status last verified
- Jan 2024
- First submitted
- 28 Feb 2019
- Last updated
- 21 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Jong JCBC, Jameson TSO, Andrews RC, Dunlop MV, Abdelrahman DR, Murton AJ, Caspers MPM, Worms N, van Nieuwkoop A, Keijzer N, Cheng Q, Guigas B, van Duijn E, Vaes WHJ, Nieuwenhuizen AG, Keijer J, Wall BT, Verschuren L, Stephens FB, van den Hoek AM, Dirks ML. Anabolic Effects of Salbutamol Are Lost Upon Immobilization. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70114. doi: 10.1002/jcsm.70114.
PubMed 41194654
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acipimox and Salbutamol Supplementation on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers
- ClinicalTrials.gov ID
- NCT03866512
- Acronym / sponsor ID
- 250839
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will investigate the impact of altered substrate availability on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization
Detailed description
Thirty-six healthy young volunteers will undergo 2 days of forearm immobilization combined with ingestion of one of two drug or placebo. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acipimox ingestion during immobilization | Experimental | Behavioral: Forearm immobilizationOral ingestion of Acipimox during 2 days of forearm immobilization |
| B-agonist during immobilization | Experimental | Behavioral: Forearm immobilizationOral ingestion of salbutamol during 2 days of forearm immobilization |
| Placebo ingestion during immobilization | Placebo comparator | Behavioral: Forearm immobilizationOral ingestion of a placebo 2 days of forearm immobilization |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and females 18-40 years of age
- Body mass index between 18 and 27
Key exclusion criteria (17 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
- Any diagnosed cardiovascular disease
- Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
- Regular use of nutritional supplements
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 |
|---|---|---|
| Forearm immobilizationTwo days of forearm immobilization | Behavioural | Acipimox ingestion during immobilization, B-agonist during immobilization, Placebo ingestion during immobilization |
Primary outcome
Percent Change in Forearm Glucose Uptake
Time frame: During the steady-state phase of the insulin clamp (i.e. last 30 min)
Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions
1 secondary outcome
Percent Change in Muscle Protein Synthesis
Time frame: In the fasted state (30 min before starting insulin clamp), and during the steady-state phase of the insulin clamp (i.e. last 30 min)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41194654de Jong JCBC, Jameson TSO, Andrews RC, Dunlop MV, Abdelrahman DR, Murton AJ, Caspers MPM, Worms N, van Nieuwkoop A, Keijzer N, Cheng Q, Guigas B, van Duijn E, Vaes WHJ, Nieuwenhuizen AG, Keijer J, Wall BT, Verschuren L, Stephens FB, van den Hoek AM, Dirks ML. Anabolic Effects of Salbutamol Are Lost Upon Immobilization. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70114. doi: 10.1002/jcsm.70114.
- Individual participant dataSharing planned: No
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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.
Marlou Dirks, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm immobilization in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
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 2 inclusion and 17 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Forearm Glucose Uptake (time frame: During the steady-state phase of the insulin clamp (i.e. last 30 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866512, which also lists 1 linked publication.
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 21 Jun 2024.