Trial Outcomes & Findings for Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls (NCT NCT00837590)
NCT ID: NCT00837590
Last Updated: 2019-08-01
Results Overview
The primary endpoints of interest is flow-mediated vasodilation
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)
Results posted on
2019-08-01
Participant Flow
All subjects were self-referred to the clinic for this study.
Subjects were excluded primarily for anemia based on screening labs or failure to return for clinic visits.
Participant milestones
| Measure |
Acute Salsalate
Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at after a single oral dose of salsalate
|
Chronic Salsalate - Obese
Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
|
Chronic Salsalate - Lean
Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
Baseline characteristics by cohort
| Measure |
Acute Salsalate
n=6 Participants
Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single dose of salsalate.
salsalate : Subjects will receive a single day of 4 gram/day of oral salsalate divided into 3 doses.
|
Chronic Salsalate - Lean
n=5 Participants
Nondiabetic lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
Salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
|
Chronic Salsalate - Obese
n=5 Participants
Nondiabetic obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
Salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
|
Total
n=16 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)Population: Pilot study. Analyzing data from all participants completing treatment.
The primary endpoints of interest is flow-mediated vasodilation
Outcome measures
| Measure |
Acute Salsalate
n=6 Participants
Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single oral dose of salsalate
|
Chronic Salsalate - Obese
n=5 Participants
Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
|
Chronic Salsalate - Lean
n=5 Participants
Lean subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
salsalate : Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
|
|---|---|---|---|
|
Vascular Function
Baseline
|
5.4 ml/min
Standard Deviation 2.3
|
6.7 ml/min
Standard Deviation 1.7
|
8.3 ml/min
Standard Deviation 2.8
|
|
Vascular Function
Salsalate
|
5.6 ml/min
Standard Deviation 1.5
|
4.4 ml/min
Standard Deviation 2.8
|
7.5 ml/min
Standard Deviation 3.9
|
Adverse Events
Acute Salsalate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Salsalate - Obese
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Salsalate - Lean
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place