Obesity
Conditions
Brief summary
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).
Interventions
DRUGSodium Tungstate
Sodium Tungstate, 200 mg BID, oral route during 6 weeks
DRUGPlacebo
Placebo, BID, oral route during 6 weeks
Sponsors
Fundacio Clinic Barcelona
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight loss | six weeks |
Secondary
| Measure | Time frame |
|---|---|
| changes in caloric intake and in hungry sensation | 6 weeks |
| resting metabolic rate | 6 weeks |
| changes in lipids | 6 weeks |
| adverse events | 6 weeks |
| changes in hormonal parameters | 6 weeks |
| changes in body composition | 6 weeks |
Countries
Spain
Outcome results
None listed