Sodium Tungstate in Obesity (TROTA-1)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Sodium Tungstate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00555074

TROTA-1

EudraCT: 2006-000567-28

Details and patient eligibility

About

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).

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Sodium Tungstate

Treatment:

Drug: Sodium Tungstate

2

Placebo Comparator group

Treatment:

Drug: Placebo