Prediabetic StateNCT01099397

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

An observational study of Prediabetic State, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine if, in a subset of patients treated with a beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour oral glucose tolerance test (OGTT) compared to fasting glucose measurement. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Prediabetic State
What is being tested?: Oral glucose tolerance test
Type of treatment: Pill or oral medicine
How many people: 26 participants
Where: 1 siteUnited States
Study dates: May 2009to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinic, PEAR participants

Who may be able to join

participation in PEAR:
an average seated home DBP > 85 mmHg and home SBP < 180 mmHg.
subjects must also have an average seated (> 5 minutes) clinic DBP between 90 mmHg and 110 mmHg and SBP < 180 mmHg.

Who cannot join

secondary forms of HTN,
patients currently treated with three or more antihypertensive drugs, isolated systolic HTN,
other diseases requiring treatment with BP lowering medications,
heart rate < 55 beats/min,
known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and TIA),
diabetes mellitus (Type 1 or 2),

Show all 13Show fewer

renal insufficiency (serum creatinine > 1.5 in men or 1.4 in women),
primary renal disease,
pregnancy or lactation,
liver enzymes > 2.5 upper limits of normal,
current treatment with NSAIDS,
COX2-inhibitors,
oral contraceptives or estrogen.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Department of Community Health and Family Medicine
Gainesville, Florida, 32610

Other trials in United States

About this study

Read the detailed description

Beta-blockers and diuretics have a well-established role in treating hypertension and are frequently used first-line. However, it is increasingly evident that these medications have harmful metabolic effects. The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR - NCT00246519) study was a greater than 700 participant, randomized, parallel assignment trial, aimed at determining the genetic factors that influence response to both a beta-blocker (atenolol) and a diuretic (hydrochlorothiazide [HCTZ]). The PEAR trial design includes evaluation at baseline, after monotherapy with either medication, and after combination therapy with both medications. This pilot, PEAR sub-study aims to characterize the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an OGTT) to detect prediabetes development prior to blood pressure medication use, after monotherapy (with atenolol or HCTZ) and after combination therapy (with atenolol and HCTZ).

Conditions: Prediabetic State
Being tested: Oral glucose tolerance test
Keywords: Glucose, Glucose Tolerance Test, Insulin Resistance, Metabolic adverse effects, Hypertension, Beta-blocker, Atenolol, Diuretic, Hydrochlorothiazide, Blood pressure
Medical subject headings: Prediabetic State, Insulin Resistance, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral glucose tolerance testOther
Also called OGTT, Glucose tolerance diagnostic test, Glucose tolerance test, Glucola
For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.

Study groups in NCT01099397
Study group	Role	What they receive
PEAR Participants		All participants eligible for PEAR study. Each participant will be have fasting and oral glucose tolerance test data collected. Receives: Other: Oral glucose tolerance test

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Dec 2010

First posted7 Apr 2010 (estimated)
Study startMay 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prediabetic StateStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01099397
Sponsor's protocol ID: UFIRB2372009 - N
Other IDs: U01GM074492
Status last verified: Mar 2018
First submitted: 1 Apr 2010
Last updated: 3 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prediabetic State trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
ClinicalTrials.gov ID: NCT01099397
Acronym / sponsor ID: UFIRB2372009 - N
Conditions: Prediabetic State
Keywords: Glucose, Glucose Tolerance Test, Insulin Resistance, Metabolic adverse effects, Hypertension, Beta-blocker, Atenolol, Diuretic
Study type: Observational
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: May 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 7 Apr 2010 (estimated)
Results: Posted 3 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
PEAR Participants	–	Other: Oral glucose tolerance testAll participants eligible for PEAR study. Each participant will be have fasting and oral glucose tolerance test data collected.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care clinic, PEAR participants

Key inclusion criteria (3 listed)

participation in PEAR:

Key exclusion criteria (13 listed)

secondary forms of HTN,
patients currently treated with three or more antihypertensive drugs, isolated systolic HTN,
other diseases requiring treatment with BP lowering medications,
heart rate < 55 beats/min,
known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and TIA),

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral glucose tolerance testAlso: OGTT, Glucose tolerance diagnostic test, Glucose tolerance test, GlucolaFor assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.	Other	PEAR Participants

Primary outcome

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
Time frame: Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)
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.

Results and safety

Results posted to the registry on 3 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PEAR Sub-study Participants	39	26

Primary outcome: 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

Time frame: Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s). Number. Unit: participants

Measure	2-hour Glucose n = 26	Fasting Glucose n = 26
Prediabetic at baseline	6	8
Normal glucose at baseline	20	18
Prediabetic at 9 weeks	7	9
Normal glucose at 9 weeks	19	17
Prediabetic at 18 weeks	7	9
Normal glucose at18 weeks	15	13

2-hour Glucose vs Fasting Glucose: p = 0.41, McNemar
2-hour Glucose vs Fasting Glucose: p = 0.59, McNemar
2-hour Glucose vs Fasting Glucose: p = 0.41, McNemar

Population analysed: Only including participants with data at each time point

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PEAR Sub-study Participants	0 of 26 (0%)	0 of 26 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a pilot study to evaluate two glucose phenotypes in a small sample from a larger trial. As such, our sample size was small. Further, if participants were withdrawn from the parent trial, they were also withdrawn from the sub-study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials websiteLink provided by the sponsor.

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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
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Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie A Johnson, PharmD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prediabetic State, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01099397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.