- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555074
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
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
-
-
-
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
|
Placebo, BID, oral route during 6 weeks
|
Experimental: 1
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
Collaborators
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.
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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