ObesityPhase 2TROTA-1NCT00555074
Sodium Tungstate in Obesity
A Phase 2 study testing Sodium Tungstate in people with Obesity, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Sodium Tungstate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2007to May 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI: 30-39.9 Kg/m2
- In case of male gender, 18 to 65 years old
- In case of female gender, diagnosis of menopause
- Body weight changes < 3 kg in the last 3 months
- In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months
Who cannot join
- In case of female gender, absence of menopause
- Evidence of secondary causes of obesity
- Diabetes, type II
- Concomitant treatment with drugs affecting body weight
- Previous surgical intervention of obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity
The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).
- Conditions
- Obesity
- Being tested
- Sodium Tungstate, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium TungstateDrug
Sodium Tungstate, 200 mg BID, oral route during 6 weeks
PlaceboDrug
Placebo, BID, oral route during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sodium Tungstate Receives: Drug: Sodium Tungstate |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: six weeks
Secondary outcomes (6)
changes in lipids
Measured: 6 weeks
changes in caloric intake and in hungry sensation
Measured: 6 weeks
resting metabolic rate
Measured: 6 weeks
changes in body composition
Measured: 6 weeks
adverse events
Measured: 6 weeks
changes in hormonal parameters
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio Clinic Barcelona
- Investigators
- Josep Vidal, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555074
- Sponsor's protocol ID
- TROTA-1
- Other IDs
- EudraCT: 2006-000567-28
- Acronym
- TROTA-1
- Status last verified
- May 2008
- First submitted
- 6 Nov 2007
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanzu F, Gomis R, Coves MJ, Viaplana J, Palomo M, Andreu A, Szpunar J, Vidal J. Proof-of-concept trial on the efficacy of sodium tungstate in human obesity. Diabetes Obes Metab. 2010 Nov;12(11):1013-8. doi: 10.1111/j.1463-1326.2010.01293.x.
PubMed 20880348
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity
- ClinicalTrials.gov ID
- NCT00555074
- Acronym / sponsor ID
- TROTA-1 / TROTA-1
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fundacio Clinic Barcelona
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Nov 2007 (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 compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sodium TungstateSodium Tungstate |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI: 30-39.9 Kg/m2
- In case of male gender, 18 to 65 years old
- In case of female gender, diagnosis of menopause
- Body weight changes < 3 kg in the last 3 months
- In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months
Key exclusion criteria (5 listed)
- In case of female gender, absence of menopause
- Evidence of secondary causes of obesity
- Diabetes, type II
- Concomitant treatment with drugs affecting body weight
- Previous surgical intervention of obesity
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 |
|---|---|---|
| Sodium TungstateSodium Tungstate, 200 mg BID, oral route during 6 weeks | Drug | 1 |
| PlaceboPlacebo, BID, oral route during 6 weeks | Drug | 2 |
Primary outcome
weight loss
Time frame: six weeks
6 secondary outcomes
changes in lipids
Time frame: 6 weeks
changes in caloric intake and in hungry sensation
Time frame: 6 weeks
resting metabolic rate
Time frame: 6 weeks
changes in body composition
Time frame: 6 weeks
adverse events
Time frame: 6 weeks
changes in hormonal parameters
Time frame: 6 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 31 Mar 2010.
- Derived from this study: PubMed 20880348Hanzu F, Gomis R, Coves MJ, Viaplana J, Palomo M, Andreu A, Szpunar J, Vidal J. Proof-of-concept trial on the efficacy of sodium tungstate in human obesity. Diabetes Obes Metab. 2010 Nov;12(11):1013-8. doi: 10.1111/j.1463-1326.2010.01293.x.
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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.
Josep Vidal, MD principal investigator
Hospital Clinic of Barcelona
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 Sodium Tungstate in people with Obesity, run by Hospital Clinic of Barcelona 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 5 inclusion and 5 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 31 Mar 2010. 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. Some participants in this study may receive a placebo. 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?
weight loss (time frame: six weeks). 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 NCT00555074, which also lists 1 linked publication.
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 31 Mar 2010.