Sodium Tungstate in Obesity - Full Text View

Sponsors and Collaborators:	Hospital Clinic of Barcelona Fundacio Clinic
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00555074

Purpose

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).

Condition	Intervention	Phase
Obesity	Drug: Sodium Tungstate Drug: Placebo	Phase II

MedlinePlus related topics: Dietary Sodium Obesity Weight Control

Drug Information available for: Sodium tungstate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Secondary Outcome Measures:

changes in lipids [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in caloric intake and in hungry sensation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
resting metabolic rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in body composition [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in hormonal parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sodium Tungstate	Drug: Sodium Tungstate Sodium Tungstate, 200 mg BID, oral route during 6 weeks
2: Placebo Comparator	Drug: Placebo Placebo, BID, oral route during 6 weeks

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555074

Contacts

Contact: Josep Vidal, MD

+34932275400 ext 3099

Locations

Spain
Hospiral Clinic de Barcelona	Recruiting
Barcelona, Spain, 08036
Contact: Josep Vidal, MD +34932275400 ext 3099 jovidal@clinic.ub.es
Principal Investigator: Josep Vidal, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Fundacio Clinic

Investigators

Principal Investigator:

Josep Vidal, MD

Hospital Clinic de Barcelona

More Information

Responsible Party:	Hospital Clinic Barcelona ( Josep Vidal )
Study ID Numbers:	TROTA-1, EudraCT: 2006-000567-28
Study First Received:	November 6, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00555074
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 15, 2009