Sodium Tungstate in Obesity

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: Sodium Tungstate

• Registration Number: NCT00555074
• Lead Sponsor: Hospital Clinic of Barcelona

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 available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Status Verified: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2010-03-30
• Last Update Posted: 2010-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Sodium Tungstate	Sodium Tungstate

Primary Outcome Measures

Name	Time	Method
weight loss	six weeks

Secondary Outcome Measures

Name	Time	Method
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
changes in hormonal parameters	6 weeks

Trial Locations

Locations (1)

Hospiral Clinic de Barcelona; 🇪🇸 Barcelona, Spain