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| ID | Type | Description | Link |
|---|---|---|---|
| 209198/Z/17/Z | Other Grant/Funding Number | Wellcome Trust |
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acipimox ingestion during immobilization | Experimental | Oral ingestion of Acipimox during 2 days of forearm immobilization |
|
| B-agonist during immobilization | Experimental | Oral ingestion of salbutamol during 2 days of forearm immobilization |
|
| Placebo ingestion during immobilization | Placebo Comparator | Oral ingestion of a placebo 2 days of forearm immobilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forearm immobilization | Behavioral | Two days of forearm immobilization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Forearm Glucose Uptake | Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions | During the steady-state phase of the insulin clamp (i.e. last 30 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Muscle Protein Synthesis | Percent change in muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlou Dirks, PhD | University of Exeter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Exeter & Devon NHS Foundation Trust | Exeter | Devon | United Kingdom |
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A total of 57 participants were screened for their eligibility to taking part.
n=6 were excluded, for the following reasons: n=5 BMI exceeding upper cut-off n=1 metabolic disease
Of the remaining n=51, n=14 chose to not continue with the study.
Of the remaining n=37, n=30 completed the study (n=3 data collection unsuccessful because of intravenous cannulation issues, n=4 dropped out)
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| ID | Title | Description |
|---|---|---|
| FG000 | Acipimox Ingestion During Immobilization | Oral ingestion of Acipimox during 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
| FG001 | B-agonist During Immobilization | Oral ingestion of salbutamol during 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
| FG002 | Placebo Ingestion During Immobilization | Oral ingestion of a placebo 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All completed participants were included in the analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | Acipimox Ingestion During Immobilization | Oral ingestion of Acipimox during 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
| BG001 | B-agonist During Immobilization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Forearm Glucose Uptake | Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions | All participants with completed data collection were included in the analysis | Posted | Mean | Standard Error | Percent change in clamp FGU with immob | During the steady-state phase of the insulin clamp (i.e. last 30 min) |
|
Adverse event data were collected throughout the entire study, up to 48h following the final study visit
All participants were instructed to notify the PI of any adverse events that occurred during their enrollment in the study, and up to 48h following completion of the final study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acipimox Ingestion During Immobilization | Oral ingestion of Acipimox during 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Product Issues | Non-systematic Assessment | Nausea and vomiting at the end of the hyperinsulinaemic-euglycaemic clamp with amino acid co-infusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marlou Dirks | University of Exeter | +44 1392 725496 | m.dirks@exeter.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | Jan 5, 2023 | Prot_SAP_000.pdf |
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Double-blind study design
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
| BG002 | Placebo Ingestion During Immobilization | Oral ingestion of a placebo 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg^m2 |
|
| Fat mass percentage | Mean | Standard Deviation | percentage of body fat |
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| Systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| OG002 | Placebo Ingestion During Immobilization | Oral ingestion of a placebo 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization |
|
|
| Secondary | Percent Change in Muscle Protein Synthesis | Percent change in muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion | All participants who completed data collection were included in the analysis | Posted | Mean | Standard Error | Percent change in clamp phenylalanine Rd | 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) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | B-agonist During Immobilization | Oral ingestion of salbutamol during 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization | 0 | 11 | 0 | 11 | 4 | 11 |
| EG002 | Placebo Ingestion During Immobilization | Oral ingestion of a placebo 2 days of forearm immobilization Forearm immobilization: Two days of forearm immobilization | 0 | 9 | 0 | 9 | 1 | 9 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|