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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00555074 |
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Date of registration:
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06/11/2007 |
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Primary sponsor: |
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Public title:
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Sodium Tungstate in Obesity
TROTA-1 |
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Scientific title:
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Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00555074 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Contacts
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Name:
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Josep Vidal, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Clinic de Barcelona |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Drug: Placebo
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Drug: Sodium Tungstate
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Primary Outcome(s)
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weight loss
[Time Frame: six weeks]
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Secondary Outcome(s)
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adverse events
[Time Frame: 6 weeks]
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changes in body composition
[Time Frame: 6 weeks]
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changes in caloric intake and in hungry sensation
[Time Frame: 6 weeks]
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changes in hormonal parameters
[Time Frame: 6 weeks]
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changes in lipids
[Time Frame: 6 weeks]
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resting metabolic rate
[Time Frame: 6 weeks]
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Secondary ID(s)
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EudraCT: 2006-000567-28
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TROTA-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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