Metabolic SyndromePhase 2NCT00639756
The Effect of Allopurinol on Insulin Resistance and Blood Pressure
A Phase 2 study testing Allopurinol in people with Metabolic Syndrome, run by Hospital Mateo Orfila at 1 site in Spain.
Trial summary
Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2008to Oct 2008
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males, age 40 -65 yrs
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion
Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.
Read the detailed description
60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.
- Conditions
- Metabolic Syndrome
- Being tested
- Allopurinol, Placebo
- Keywords
- Uric acid, Fructose, Hypertension, Insulin, Glucose, HOMA
- Medical subject headings
- Metabolic Syndrome, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Allopurinol 300 mg
PlaceboDrug
Placebo given for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Placebo Receives: Drug: Placebo |
| 2 | Active comparator | Allopurinol given for 2 weeks with diet Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance (HOMA index)
Measured: 2 weeks
Blood pressure
Measured: 2 weeks
Triglycerides, HDL cholesterol
Measured: 2 weeks
Secondary outcomes (4)
Adiponectin
Measured: 2 weeks
Leptin
Measured: 2 weeks
CRP level
Measured: 2 weeks
Weight gain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionOct 2008
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 Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mateo Orfila
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639756
- Sponsor's protocol ID
- IbSalut-M-001
- Status last verified
- Oct 2008
- First submitted
- 10 Mar 2008
- Last updated
- 13 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson RJ, Perez-Pozo SE, Lillo JL, Grases F, Schold JD, Kuwabara M, Sato Y, Hernando AA, Garcia G, Jensen T, Rivard C, Sanchez-Lozada LG, Roncal C, Lanaspa MA. Fructose increases risk for kidney stones: potential role in metabolic syndrome and heat stress. BMC Nephrol. 2018 Nov 8;19(1):315. doi: 10.1186/s12882-018-1105-0.
PubMed 30409184Perez-Pozo SE, Schold J, Nakagawa T, Sanchez-Lozada LG, Johnson RJ, Lillo JL. Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response. Int J Obes (Lond). 2010 Mar;34(3):454-61. doi: 10.1038/ijo.2009.259. Epub 2009 Dec 22.
PubMed 20029377
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion
- ClinicalTrials.gov ID
- NCT00639756
- Acronym / sponsor ID
- IbSalut-M-001
- Conditions
- Metabolic Syndrome
- Keywords
- Uric acid, Fructose, Hypertension, Insulin, Glucose, HOMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Mateo OrfilaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Mar 2008 (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.
Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.
Detailed description
60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: PlaceboPlacebo |
| 2 | Active comparator | Drug: AllopurinolAllopurinol given for 2 weeks with diet |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males, age 40 -65 yrs
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AllopurinolAllopurinol 300 mg | Drug | 2 |
| PlaceboPlacebo given for 2 weeks | Drug | 1 |
Primary outcome
Insulin resistance (HOMA index)
Time frame: 2 weeks
Blood pressure
Time frame: 2 weeks
Triglycerides, HDL cholesterol
Time frame: 2 weeks
4 secondary outcomes
Adiponectin
Time frame: 2 weeks
Leptin
Time frame: 2 weeks
CRP level
Time frame: 2 weeks
Weight gain
Time frame: 2 weeks
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 13 Oct 2008.
- Derived from this study: PubMed 30409184Johnson RJ, Perez-Pozo SE, Lillo JL, Grases F, Schold JD, Kuwabara M, Sato Y, Hernando AA, Garcia G, Jensen T, Rivard C, Sanchez-Lozada LG, Roncal C, Lanaspa MA. Fructose increases risk for kidney stones: potential role in metabolic syndrome and heat stress. BMC Nephrol. 2018 Nov 8;19(1):315. doi: 10.1186/s12882-018-1105-0.
- Derived from this study: PubMed 20029377Perez-Pozo SE, Schold J, Nakagawa T, Sanchez-Lozada LG, Johnson RJ, Lillo JL. Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response. Int J Obes (Lond). 2010 Mar;34(3):454-61. doi: 10.1038/ijo.2009.259. Epub 2009 Dec 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Metabolic Syndrome, run by Hospital Mateo Orfila at 1 site in Spain.
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 1 inclusion and 1 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 13 Oct 2008. 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 Spain. 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?
Insulin resistance (HOMA index) (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 NCT00639756, 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 13 Oct 2008.