Sodium Tungstate in Obesity

NCT ID: NCT00555074

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Sodium Tungstate

Group Type EXPERIMENTAL

Sodium Tungstate

Intervention Type DRUG

Sodium Tungstate, 200 mg BID, oral route during 6 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, BID, oral route during 6 weeks

Interventions

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Sodium Tungstate

Sodium Tungstate, 200 mg BID, oral route during 6 weeks

Intervention Type DRUG

Placebo

Placebo, BID, oral route during 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio Clinic Barcelona

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic Barcelona

Principal Investigators

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Josep Vidal, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospiral Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 20880348 (View on PubMed)

Other Identifiers

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EudraCT: 2006-000567-28

Identifier Type: -

Identifier Source: secondary_id

TROTA-1

Identifier Type: -

Identifier Source: org_study_id