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Completed

NCT Number: NCT00555074

Sodium Tungstate in Obesity

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospiral Clinic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Tungstate

Drug

Sodium Tungstate, 200 mg BID, oral route during 6 weeks

Placebo

Drug

Placebo, BID, oral route during 6 weeks

Primary outcomes

  1. weight loss

    Time frame: six weeks

Secondary outcomes

  1. changes in lipids

    Time frame: 6 weeks

  2. changes in caloric intake and in hungry sensation

    Time frame: 6 weeks

  3. resting metabolic rate

    Time frame: 6 weeks

  4. changes in body composition

    Time frame: 6 weeks

  5. adverse events

    Time frame: 6 weeks

  6. changes in hormonal parameters

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundacio Clinic Barcelona

Registry information

Official study title

Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity

Acronym: TROTA-1

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 7, 2007
Registry last updated
Mar 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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