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Sodium Tungstate in Obesity (TROTA-1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555074
First Posted: November 7, 2007
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundacio Clinic
Information provided by:
Hospital Clinic of Barcelona
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • weight loss [ Time Frame: six weeks ]

Secondary Outcome Measures:
  • changes in lipids [ Time Frame: 6 weeks ]
  • changes in caloric intake and in hungry sensation [ Time Frame: 6 weeks ]
  • resting metabolic rate [ Time Frame: 6 weeks ]
  • changes in body composition [ Time Frame: 6 weeks ]
  • adverse events [ Time Frame: 6 weeks ]
  • changes in hormonal parameters [ Time Frame: 6 weeks ]

Estimated Enrollment: 44
Study Start Date: November 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sodium Tungstate
Drug: Sodium Tungstate
Sodium Tungstate, 200 mg BID, oral route during 6 weeks
Placebo Comparator: 2 Drug: Placebo
Placebo, BID, oral route during 6 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555074


Locations
Spain
Hospiral Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fundacio Clinic
Investigators
Principal Investigator: Josep Vidal, MD Hospital Clinic of Barcelona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josep Vidal, Hospital Clinic Barcelona
ClinicalTrials.gov Identifier: NCT00555074     History of Changes
Other Study ID Numbers: TROTA-1
EudraCT: 2006-000567-28
First Submitted: November 6, 2007
First Posted: November 7, 2007
Last Update Posted: March 31, 2010
Last Verified: May 2008

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms