Sodium Tungstate in Obesity | NCT00555074

Studies
Sodium Tungstate in Obesity

NCT00555074

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Mar 31, 2010Estimated

Enrollment

44Estimated

Phase

Phase 2

Conditions

Obesity

Interventions

Sodium Tungstate
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT: 2006-000567-28

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Nov 6, 2007

First Submission Date that Met QC Criteria

Nov 6, 2007

First Posted Date

Nov 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2010

Last Update Posted Date

Mar 31, 2010Estimated

Name	Class
Fundacio Clinic Barcelona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Sodium Tungstate	Drug: Sodium Tungstate
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium Tungstate	Drug	Sodium Tungstate, 200 mg BID, oral route during 6 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss		six weeks

Secondary Outcomes

Measure	Description	Time Frame
changes in lipids		6 weeks
changes in caloric intake and in hungry sensation		6 weeks
resting metabolic rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Josep Vidal, MD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospiral Clinic de Barcelona		Barcelona	Barcelona	08036	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20880348	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases