Trial Outcomes & Findings for Aldosterone and Glucose Homeostasis (NCT NCT00732160)
NCT ID: NCT00732160
Last Updated: 2017-04-06
Results Overview
Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
3 hours
Results posted on
2017-04-06
Participant Flow
11 participants did not start the study (5 Participants did Not Meet inclusion or exclusion criteria, 6 declined participation)
Participant milestones
| Measure |
HS-V/A; LS-V/A
High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
|
HS-A/V; LS-A/V
High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
|
LS-V/A; HS-V/A
Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
|
LS-A/V; HS-A/V
Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
6
|
5
|
|
Overall Study
HS Vehicle
|
7
|
5
|
3
|
3
|
|
Overall Study
HS Aldosterone
|
7
|
5
|
3
|
3
|
|
Overall Study
LS Vehicle
|
2
|
1
|
6
|
5
|
|
Overall Study
LS Aldosterone
|
2
|
1
|
6
|
5
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
HS-V/A; LS-V/A
High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
|
HS-A/V; LS-A/V
High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
|
LS-V/A; HS-V/A
Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
|
LS-A/V; HS-A/V
Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
|
Overall Study
scheduling
|
4
|
4
|
2
|
1
|
Baseline Characteristics
Aldosterone and Glucose Homeostasis
Baseline characteristics by cohort
| Measure |
HS-V/A; LS-V/A
n=7 Participants
High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
|
HS-A/V; LS-A/V
n=5 Participants
High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
|
LS-V/A; HS-V/A
n=6 Participants
Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
|
LS-A/V; HS-A/V
n=5 Participants
Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.1 years
n=5 Participants
|
29.2 years
n=7 Participants
|
32.5 years
n=5 Participants
|
27.2 years
n=4 Participants
|
28.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Glucose (mg/dL)
|
85.3 mg/dL
STANDARD_DEVIATION 7.6 • n=5 Participants
|
85.4 mg/dL
STANDARD_DEVIATION 7.2 • n=7 Participants
|
85.3 mg/dL
STANDARD_DEVIATION 7.6 • n=5 Participants
|
85.4 mg/dL
STANDARD_DEVIATION 7.2 • n=4 Participants
|
85.3 mg/dL
STANDARD_DEVIATION 7.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: 3 hoursPopulation: Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.
Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)
Outcome measures
| Measure |
Vehicle, HS
n=17 Participants
Vehicle Infusion, High Salt diet
|
Vehicle, LS
n=12 Participants
Vehicle Infusion, Low Salt diet
|
Aldosterone, HS
n=17 Participants
Aldosterone Infusion, High Salt diet
|
Aldosterone, LS
n=12 Participants
Aldosterone Infusion, Low Salt diet
|
|---|---|---|---|---|
|
Insulin Secretion
|
48.9 uU/mL
Standard Deviation 34.8
|
37.6 uU/mL
Standard Deviation 30.9
|
51.8 uU/mL
Standard Deviation 40.2
|
34.4 uU/mL
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 3 hoursPopulation: Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.
Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.
Outcome measures
| Measure |
Vehicle, HS
n=17 Participants
Vehicle Infusion, High Salt diet
|
Vehicle, LS
n=12 Participants
Vehicle Infusion, Low Salt diet
|
Aldosterone, HS
n=17 Participants
Aldosterone Infusion, High Salt diet
|
Aldosterone, LS
n=12 Participants
Aldosterone Infusion, Low Salt diet
|
|---|---|---|---|---|
|
Insulin Sensitivity
|
25.2 mg/kg/min per uU/mL*100
Standard Deviation 15.4
|
24.8 mg/kg/min per uU/mL*100
Standard Deviation 16.4
|
23.4 mg/kg/min per uU/mL*100
Standard Deviation 17.3
|
24.7 mg/kg/min per uU/mL*100
Standard Deviation 13.4
|
Adverse Events
Vehicle, HS
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle, LS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Aldosterone, HS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Aldosterone, LS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle, HS
n=18 participants at risk
Vehicle Infusion, High Salt diet
|
Vehicle, LS
n=14 participants at risk
Vehicle Infusion, Low Salt diet
|
Aldosterone, HS
n=18 participants at risk
Aldosterone Infusion, High Salt diet
|
Aldosterone, LS
n=14 participants at risk
Aldosterone Infusion, Low Salt diet
|
|---|---|---|---|---|
|
Renal and urinary disorders
Low potassium
|
5.6%
1/18 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
|
Blood and lymphatic system disorders
IV site discomfort
|
5.6%
1/18 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Lightheadedness
|
5.6%
1/18 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
tachycardia
|
0.00%
0/18
|
0.00%
0/14
|
5.6%
1/18 • Number of events 1
|
0.00%
0/14
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/18
|
7.1%
1/14 • Number of events 1
|
0.00%
0/18
|
0.00%
0/14
|
|
General disorders
Nasal congestion or rhinorrhea
|
11.1%
2/18 • Number of events 2
|
0.00%
0/14
|
0.00%
0/18
|
0.00%
0/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place