Sodium Tungstate in Obesity (TROTA-1)

March 30, 2010 updated by: Hospital Clinic of Barcelona

Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospiral Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Placebo, BID, oral route during 6 weeks
Experimental: 1
Sodium Tungstate
Drug: Sodium Tungstate
Sodium Tungstate, 200 mg BID, oral route during 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 6 weeks
6 weeks
changes in lipids
Time Frame: 6 weeks
6 weeks
changes in caloric intake and in hungry sensation
Time Frame: 6 weeks
6 weeks
resting metabolic rate
Time Frame: 6 weeks
6 weeks
changes in body composition
Time Frame: 6 weeks
6 weeks
changes in hormonal parameters
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacio Clinic Barcelona

Investigators

  • Principal Investigator: Josep Vidal, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 6, 2007

First Submitted That Met QC Criteria

November 6, 2007

First Posted (Estimate)

November 7, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROTA-1
  • EudraCT: 2006-000567-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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