Trial Outcomes & Findings for Forearm Immobilization, Metabolic Health, and Muscle Loss (NCT NCT03866512)
NCT ID: NCT03866512
Last Updated: 2024-06-21
Results Overview
Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
During the steady-state phase of the insulin clamp (i.e. last 30 min)
Results posted on
2024-06-21
Participant Flow
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)
Participant milestones
| Measure |
Acipimox Ingestion During Immobilization
Oral ingestion of Acipimox during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
B-agonist During Immobilization
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Placebo Ingestion During Immobilization
Oral ingestion of a placebo 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
14
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Acipimox Ingestion During Immobilization
Oral ingestion of Acipimox during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
B-agonist During Immobilization
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Placebo Ingestion During Immobilization
Oral ingestion of a placebo 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Cannulation issues
|
0
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acipimox Ingestion During Immobilization
n=10 Participants
Oral ingestion of Acipimox during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
B-agonist During Immobilization
n=11 Participants
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Placebo Ingestion During Immobilization
n=9 Participants
Oral ingestion of a placebo 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
21 years
STANDARD_DEVIATION 3 • n=10 Participants
|
23 years
STANDARD_DEVIATION 4 • n=11 Participants
|
23 years
STANDARD_DEVIATION 7 • n=9 Participants
|
22 years
STANDARD_DEVIATION 5 • n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
5 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
6 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
16 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
9 participants
n=9 Participants
|
30 participants
n=30 Participants
|
|
Body mass index
|
22.9 kg^m2
STANDARD_DEVIATION 2.7 • n=10 Participants
|
24.1 kg^m2
STANDARD_DEVIATION 3.5 • n=11 Participants
|
23.9 kg^m2
STANDARD_DEVIATION 2.1 • n=9 Participants
|
23.7 kg^m2
STANDARD_DEVIATION 2.8 • n=30 Participants
|
|
Fat mass percentage
|
20.9 percentage of body fat
STANDARD_DEVIATION 9.4 • n=10 Participants
|
24.4 percentage of body fat
STANDARD_DEVIATION 12.1 • n=11 Participants
|
25.1 percentage of body fat
STANDARD_DEVIATION 9.2 • n=9 Participants
|
23.5 percentage of body fat
STANDARD_DEVIATION 10.2 • n=30 Participants
|
|
Systolic blood pressure
|
117 mmHg
STANDARD_DEVIATION 11 • n=10 Participants
|
111 mmHg
STANDARD_DEVIATION 9 • n=11 Participants
|
114 mmHg
STANDARD_DEVIATION 44 • n=9 Participants
|
114 mmHg
STANDARD_DEVIATION 10 • n=30 Participants
|
|
Diastolic blood pressure
|
69 mmHg
STANDARD_DEVIATION 6 • n=10 Participants
|
70 mmHg
STANDARD_DEVIATION 5 • n=11 Participants
|
65 mmHg
STANDARD_DEVIATION 6 • n=9 Participants
|
68 mmHg
STANDARD_DEVIATION 4 • n=30 Participants
|
PRIMARY outcome
Timeframe: During the steady-state phase of the insulin clamp (i.e. last 30 min)Population: All participants with completed data collection were included in the analysis
Insulin sensitivity, measured as forearm glucose uptake, during a 30-min baseline period and hyperinsulinaemic-euglycaemic conditions
Outcome measures
| Measure |
Acipimox Ingestion During Immobilization
n=10 Participants
Oral ingestion of Acipimox during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
B-agonist During Immobilization
n=11 Participants
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Placebo Ingestion During Immobilization
n=9 Participants
Oral ingestion of a placebo 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
|---|---|---|---|
|
Percent Change in Forearm Glucose Uptake
|
-73 Percent change in clamp FGU with immob
Standard Error 15
|
127 Percent change in clamp FGU with immob
Standard Error 134
|
-95 Percent change in clamp FGU with immob
Standard Error 113
|
SECONDARY outcome
Timeframe: 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)Population: All participants who completed data collection were included in the analysis
Percent change in muscle protein synthesis, measured as using the arteriovenous-venous method, via stable isotope tracer infusion
Outcome measures
| Measure |
Acipimox Ingestion During Immobilization
n=8 Participants
Oral ingestion of Acipimox during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
B-agonist During Immobilization
n=11 Participants
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Placebo Ingestion During Immobilization
n=9 Participants
Oral ingestion of a placebo 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
|---|---|---|---|
|
Percent Change in Muscle Protein Synthesis
|
-93 Percent change in clamp phenylalanine Rd
Standard Error 40
|
-124 Percent change in clamp phenylalanine Rd
Standard Error 29
|
-251 Percent change in clamp phenylalanine Rd
Standard Error 145
|
Adverse Events
Acipimox Ingestion During Immobilization
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
B-agonist During Immobilization
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Ingestion During Immobilization
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acipimox Ingestion During Immobilization
n=10 participants at risk
Oral ingestion of Acipimox during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
B-agonist During Immobilization
n=11 participants at risk
Oral ingestion of salbutamol during 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
Placebo Ingestion During Immobilization
n=9 participants at risk
Oral ingestion of a placebo 2 days of forearm immobilization
Forearm immobilization: Two days of forearm immobilization
|
|---|---|---|---|
|
Product Issues
Nausea and vomiting
|
10.0%
1/10 • Number of events 1 • 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.
|
36.4%
4/11 • Number of events 4 • 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.
|
11.1%
1/9 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place