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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014