Trial Outcomes & Findings for Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study (NCT NCT01099397)

Results Overview

A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.

Recruitment status

COMPLETED

Target enrollment

26 participants

Primary outcome timeframe

Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)

Results posted on

2018-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	PEAR Sub-study Participants All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
Overall Study STARTED	39
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	PEAR Sub-study Participants All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
Overall Study Lost to Follow-up	4
Overall Study Protocol Violation	4
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEAR Sub-study Participants n=26 Participants All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)

Population: Only including participants with data at each time point

A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.

Outcome measures

Outcome measures
Measure	2-hour Glucose n=26 Participants Glucose collected after a 2 hour oral glucose tolerance test	Fasting Glucose n=26 Participants Fasting glucose collected
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment Prediabetic at baseline	6 participants	8 participants
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment Normal glucose at baseline	20 participants	18 participants
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment Prediabetic at 9 weeks	7 participants	9 participants
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment Normal glucose at 9 weeks	19 participants	17 participants
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment Prediabetic at 18 weeks	7 participants	9 participants
Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment Normal glucose at18 weeks	15 participants	13 participants

Adverse Events

PEAR Sub-study Participants

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

Mariellen Moore

University of Florida

Phone: 352-273-6381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place