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Sodium Tungstate in Obesity (TROTA-1)

This study has been completed.
Sponsor:
Collaborator:
Fundacio Clinic
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00555074
First received: November 6, 2007
Last updated: March 30, 2010
Last verified: May 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • weight loss [ Time Frame: six weeks ] [ Designated as safety issue: No ]

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
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 de Barcelona
  More Information

No publications provided

Responsible Party: Josep Vidal, Hospital Clinic Barcelona
ClinicalTrials.gov Identifier: NCT00555074     History of Changes
Other Study ID Numbers: TROTA-1, EudraCT: 2006-000567-28
Study First Received: November 6, 2007
Last Updated: March 30, 2010
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on May 16, 2013