NCT00555074

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 31, 2010

Status Verified

May 1, 2008

Enrollment Period

1.5 years

First QC Date

November 6, 2007

Last Update Submit

March 30, 2010

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    six weeks

Secondary Outcomes (6)

  • changes in lipids

    6 weeks

  • changes in caloric intake and in hungry sensation

    6 weeks

  • resting metabolic rate

    6 weeks

  • changes in body composition

    6 weeks

  • adverse events

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Sodium Tungstate

Drug: Sodium Tungstate

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Sodium TungstateDRUG

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

1
PlaceboDRUG

Placebo, BID, oral route during 6 weeks

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospiral Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 20880348DERIVED

MeSH Terms

Conditions

Obesity

Interventions

sodium tungstate(VI)

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Josep Vidal, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 7, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 31, 2010

Record last verified: 2008-05

Locations

ES(1)