Trial Outcomes & Findings for Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study (NCT NCT01409434)
NCT ID: NCT01409434
Last Updated: 2014-10-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
Fasting glucose was obtained at time 0 min.
Results posted on
2014-10-16
Participant Flow
Participant milestones
| Measure |
Follow-Up Arm
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Follow-Up Arm
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study
Baseline characteristics by cohort
| Measure |
Follow-Up Arm
n=44 Participants
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
|
Fasting Glucose
|
91 mg/dL
STANDARD_DEVIATION 12 • n=99 Participants
|
PRIMARY outcome
Timeframe: Fasting glucose was obtained at time 0 min.Population: A total of 44 patients were included in the study, however 4 patients were treated with anti-diabetic medications and so were excluded from the analysis. Therefore there are a total of 40 patients that were included in the analysis.
Outcome measures
| Measure |
Follow-Up Arm
n=40 Participants
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Fasting Glucose (mg/dL)
|
94 mg/dL
Standard Deviation 13
|
SECONDARY outcome
Timeframe: one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)Population: Patients that underwent an OGTT
Area under the curve for the OGTT was calculated for each patient using the 3 time points (0 hour, 1 hour and 2 hour). Average value for participants is provided.
Outcome measures
| Measure |
Follow-Up Arm
n=40 Participants
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Oral Glucose Tolerance Test (mg/dl h)
|
273 mg/dL*h
Standard Deviation 74
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SECONDARY outcome
Timeframe: Triglycerides was obtained at time 0 min.Outcome measures
| Measure |
Follow-Up Arm
n=40 Participants
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Triglycerides (mg/dL)
|
157 mg/dl
Standard Deviation 89
|
SECONDARY outcome
Timeframe: Low Density Lipoprotein was obtained at time 0 min.Outcome measures
| Measure |
Follow-Up Arm
n=40 Participants
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
Low Density Lipoprotein (mg/dL)
|
117 mg/dL
Standard Deviation 36
|
SECONDARY outcome
Timeframe: High Density Lipoprotein was obtained at time 0 min.Outcome measures
| Measure |
Follow-Up Arm
n=40 Participants
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.
Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
|
|---|---|
|
High Density Lipoprotein (mg/dL)
|
52 mg/dL
Standard Deviation 17
|
Adverse Events
Follow-Up Arm
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