Trial Outcomes & Findings for Muscle Perfusion and Protein Metabolism in Elderly (NCT NCT00945256)
NCT ID: NCT00945256
Last Updated: 2016-02-03
Results Overview
The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Acute ( 8 hours)
Results posted on
2016-02-03
Participant Flow
Young groups: Ages 18 - 40; Elderly groups: Ages 60 - 85
Participant milestones
| Measure |
Young Aerobic Exercise
45 minutes of treadmill walking completed at 40% VO2 peak
|
Elderly Aerobic Exercise
45 minutes of treadmill walking at 40% VO2 peak.
|
Young Sodium Nitroprusside
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside and Amino Acid Drink
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
15
|
16
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
8
|
9
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Muscle Perfusion and Protein Metabolism in Elderly
Baseline characteristics by cohort
| Measure |
Young Aerobic Exercise
n=13 Participants
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Elderly Aerobic Exercise
n=10 Participants
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Young Sodium Nitroprusside
n=15 Participants
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside
n=16 Participants
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside and Amino Acid Drink
n=8 Participants
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
26.4 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 4.4 • n=21 Participants
|
49.2 years
STANDARD_DEVIATION 21.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
8 participants
n=21 Participants
|
62 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Acute ( 8 hours)Population: FSR was not calculated for the Elderly Sodium Nitroprusside with Amino Acid Drink arm of the study.
The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.
Outcome measures
| Measure |
Young Aerobic Exercise
n=13 Participants
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Elderly Aerobic Exercise
n=10 Participants
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Young Sodium Nitroprusside
n=15 Participants
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside (SNP)
n=16 Participants
Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside and Amino Acid Drink
n=8 Participants
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and a 7.5g amino acid drink taken orally.
|
|---|---|---|---|---|---|
|
Mixed Muscle Fractional Synthesis Rate (FSR)
Pre-intervention (either exercise or SNP)
|
0.061 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.005
|
0.070 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.006
|
0.066 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.01
|
0.070 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.004
|
NA Fractional Synthesis Rate (pecent/hour)
Standard Error NA
FSR was not calculated for this arm of the study.
|
|
Mixed Muscle Fractional Synthesis Rate (FSR)
Post -intervention (either exercise or SNP)
|
0.098 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.009
|
0.111 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.011
|
0.090 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.008
|
0.095 Fractional Synthesis Rate (pecent/hour)
Standard Error 0.009
|
NA Fractional Synthesis Rate (pecent/hour)
Standard Error NA
FSR was not calculated for this arm of the study.
|
Adverse Events
Young Aerobic Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Elderly Aerobic Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Young Sodium Nitroprusside
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Elderly Sodium Nitroprusside
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Elderly Sodium Nitroprusside and Amino Acid Drink
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Young Aerobic Exercise
n=13 participants at risk
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Elderly Aerobic Exercise
n=10 participants at risk
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Young Sodium Nitroprusside
n=15 participants at risk
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside
n=16 participants at risk
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside and Amino Acid Drink
n=8 participants at risk
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/10 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/15 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
6.2%
1/16 • Number of events 1 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/8 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
Other adverse events
| Measure |
Young Aerobic Exercise
n=13 participants at risk
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Elderly Aerobic Exercise
n=10 participants at risk
45 minutes of treadmill walking completed at 40% VO2 peak.
|
Young Sodium Nitroprusside
n=15 participants at risk
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside
n=16 participants at risk
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
|
Elderly Sodium Nitroprusside and Amino Acid Drink
n=8 participants at risk
Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness at biopsy site
|
0.00%
0/13 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/10 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
6.7%
1/15 • Number of events 1 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
6.2%
1/16 • Number of events 1 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/8 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
|
Skin and subcutaneous tissue disorders
Swelling at femoral catheter site
|
0.00%
0/13 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/10 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
6.7%
1/15 • Number of events 1 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/16 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/8 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/13 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/10 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/15 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
6.2%
1/16 • Number of events 1 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
0.00%
0/8 • Time frame for Adverse Event Reporting is the study date and one week past the study date to assess any problems with muscle biopsies, catheter placement.
Adverse events were self reported by subjects to clinical research staff.
|
Additional Information
Dr Melinda Sheffield-Moore, Professor of Medicine
University of Texas Medical Branch
Phone: 409-772-8707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place