ObesityPhase 2NCT00288158
Primary Prevention of Hypertension in Obese Adolescents
A Phase 2 study testing Allopurinol and Probenecid in people with Obesity and Pre-Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to examine the consequences of lowering serum uric acid in pre-hypertensive, obese adolescents pathways involved with how uric acid mediated hypertension and renal disease. The specific aims are: 1. Test the hypothesis that lowering uric acid will improve endothelial function. 2. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pre-Hypertension, Hyperuricemia
- What is being tested?
- Allopurinol and Probenecid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children between the ages of 11 and 18
- body mass index greater than the 95th percentile for age
- Blood pressure between 75th and 95th percentile for age, gender and height percentile
Who cannot join
- hypertension at the time of screening
- allergy to one of the study medications
- liver function abnormality (AST or ALT greater than twice the upper limit of
- normal for the laboratory)
- history of renal stones
- renal insufficiency (Schwartz formula calculated GFR less than 70ml per min per 1.73m2 BSA)
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- positive urine pregnancy test
- diabetes
- organ transplant recipient
- currently treated with an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), diuretic, other medications known to alter serum uric acid level
- lack of ability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the consequences of lowering serum uric acid in pre-hypertensive, obese adolescents pathways involved with how uric acid mediated hypertension and renal disease. The specific aims are:
- Test the hypothesis that lowering uric acid will improve endothelial function.
- Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum angiotensin II levels.
- Test the hypothesis that lowering uric acid will reduce markers of inflammation
Read the detailed description
The trial will be a double blinded, placebo control trial of two uric acid lowering agents. The endpoints for this trial will be, endothelial function, systemic vascular resistance, plasma renin activity, MCP-1 and CRP. Upon recruitment and informed consent, children will undergo initial screening. This will include medical history, family history, dietary history, review of systems (questionnaire used and validated in pediatric hypertension clinic) and pediatric quality of life questionnaire. They will have a physical exam, casual and ambulatory blood pressure monitoring (see below) and screening laboratory analysis that will include CBC, electrolytes, BUN, Cr, Uric acid, AST, ALT and urinary micro-albumin to creatinine ratio. Children with serum uric acid less than 5.0mg per dl will be enrolled as controls and only have baseline studies at Screening and Visit 1. Children with serum uric acid equal to or greater than 5.0mg per dl will be randomized (in a one to one to one ratio) to receive placebo, allopurinol or probenecid.
Study drug (or placebo) will be administered for 2 months. During the first week, subjects will take one tablet (placebo, 150mg allopurinol or 250mg probenecid) twice daily. At the end of one week subjects will be instructed to increase to 2 tablets (placebo, 300mg allopurinol or 500mg probenecid) twice daily. Data collection will occur during screening, after one and two months on the study drug and one month after completion of the study drug.
- Conditions
- Obesity, Pre-Hypertension, Hyperuricemia
- Being tested
- Allopurinol, Probenecid, Placebo
- Medical subject headings
- Obesity, Prehypertension, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
ProbenecidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | Not described Receives: Drug: Allopurinol |
| Probenecid | Experimental | Not described Receives: Drug: Probenecid |
| Placebo | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Casual BP
Measured: 3 months
Secondary outcomes (2)
24- hour Ambulatory BP
Measured: 3 months
Systemic Vascular Resistance (measured by bioimpedance)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startSep 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Baylor University
- Responsible party
- Sponsor
- Investigators
- Daniel I Feig, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288158
- Sponsor's protocol ID
- DK71223 (completed)
- Other IDs
- R21DK071223
- Status last verified
- Sep 2017
- First submitted
- 6 Feb 2006
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Soletsky B, Feig DI. Uric acid reduction rectifies prehypertension in obese adolescents. Hypertension. 2012 Nov;60(5):1148-56. doi: 10.1161/HYPERTENSIONAHA.112.196980. Epub 2012 Sep 24.
PubMed 23006736Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
PubMed 21849262
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Hypertension in Obese Adolescents
- ClinicalTrials.gov ID
- NCT00288158
- Acronym / sponsor ID
- DK71223 (completed)
- Conditions
- Obesity, Pre-Hypertension, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Baylor University
- Study start
- Sep 2008 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the consequences of lowering serum uric acid in pre-hypertensive, obese adolescents pathways involved with how uric acid mediated hypertension and renal disease. The specific aims are:
- Test the hypothesis that lowering uric acid will improve endothelial function.
- Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum angiotensin II levels.
- Test the hypothesis that lowering uric acid will reduce markers of inflammation
Detailed description
The trial will be a double blinded, placebo control trial of two uric acid lowering agents. The endpoints for this trial will be, endothelial function, systemic vascular resistance, plasma renin activity, MCP-1 and CRP. Upon recruitment and informed consent, children will undergo initial screening. This will include medical history, family history, dietary history, review of systems (questionnaire used and validated in pediatric hypertension clinic) and pediatric quality of life questionnaire. They will have a physical exam, casual and ambulatory blood pressure monitoring (see below) and screening laboratory analysis that will include CBC, electrolytes, BUN, Cr, Uric acid, AST, ALT and urinary micro-albumin to creatinine ratio. Children with serum uric acid less than 5.0mg per dl will be enrolled as controls and only have baseline studies at Screening and Visit 1. Children with serum uric acid equal to or greater than 5.0mg per dl will be randomized (in a one to one to one ratio) to receive placebo, allopurinol or probenecid.
Study drug (or placebo) will be administered for 2 months. During the first week, subjects will take one tablet (placebo, 150mg allopurinol or 250mg probenecid) twice daily. At the end of one week subjects will be instructed to increase to 2 tablets (placebo, 300mg allopurinol or 500mg probenecid) twice daily. Data collection will occur during screening, after one and two months on the study drug and one month after completion of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: Allopurinol |
| Probenecid | Experimental | Drug: Probenecid |
| Placebo | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children between the ages of 11 and 18
- body mass index greater than the 95th percentile for age
- Blood pressure between 75th and 95th percentile for age, gender and height percentile
Key exclusion criteria (11 listed)
- hypertension at the time of screening
- allergy to one of the study medications
- liver function abnormality (AST or ALT greater than twice the upper limit of
- normal for the laboratory)
- history of renal stones
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 |
|---|---|---|
| Allopurinol | Drug | Allopurinol |
| Probenecid | Drug | Probenecid |
| Placebo | Drug | Placebo |
Primary outcome
Casual BP
Time frame: 3 months
2 secondary outcomes
24- hour Ambulatory BP
Time frame: 3 months
Systemic Vascular Resistance (measured by bioimpedance)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 23006736Soletsky B, Feig DI. Uric acid reduction rectifies prehypertension in obese adolescents. Hypertension. 2012 Nov;60(5):1148-56. doi: 10.1161/HYPERTENSIONAHA.112.196980. Epub 2012 Sep 24.
- Derived from this study: PubMed 21849262Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
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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.
Daniel I Feig, MD, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol and Probenecid in people with Obesity and Pre-Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 11 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 14 Sep 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Casual BP (time frame: 3 months). 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 NCT00288158, which also lists 2 linked publications.
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 14 Sep 2017.