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Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561132
First Posted: November 20, 2007
Last Update Posted: November 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fondo para el Fomento a la Investigacion Medica
Doctorado en Farmacologia de la Universidad de Guadalajara
Information provided by:
Unidad de Investigacion Medica en Epidemiologia Clinica
  Purpose
The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity in patients with impaired glucose tolerance. Secondary purpose of this study was to assess changes on metabolic profile, weight and blood pressure.

Condition Intervention Phase
Prediabetic State Dietary Supplement: Vanadyl sulfate Other: Magnesium oxide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by Unidad de Investigacion Medica en Epidemiologia Clinica:

Primary Outcome Measures:
  • Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Changes on metabolic profile [ Time Frame: 4 weeks ]
  • Changes on anthropometrical measures [ Time Frame: 4 weeks ]

Enrollment: 14
Study Start Date: November 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Vanadyl sulfate
50 mg twice daily orally for a period of 4 weeks
Other Names:
  • Vanadyl sulphate
  • Vanadyl sulfate hydrate
  • Vanadyl sulphate hydrate
Placebo Comparator: 2 Other: Magnesium oxide
Validation of similar appearance and weight to the intervention component orally 1 unit (<50 mg) twice daily for a period of 4 weeks
Other Names:
  • Calcinated magnesia
  • Calcined Magnesite
  • Magnesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of impaired glucose tolerance
  • Body mass index from 25 to 35 kg/m2
  • History of type 2 diabetes mellitus in the first branch

Exclusion Criteria:

  • Taking medication with known effects on carbohydrate or insulin metabolism
  • Thyroid diseases
  • Hepatic diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561132


Locations
Mexico
Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente
Guadalajara, Jalisco, Mexico, 44320
Sponsors and Collaborators
Unidad de Investigacion Medica en Epidemiologia Clinica
Fondo para el Fomento a la Investigacion Medica
Doctorado en Farmacologia de la Universidad de Guadalajara
Investigators
Principal Investigator: Omar Jacques-Camarena, MD, MSc Unidad de Investigacion Medica en Epidemiologia Clinica
Principal Investigator: Manuel González-Ortiz, MD, MSc, PhD Unidad de Investigacion Medica en Epidemiologia Clinica
Study Director: Esperanza Martínez-Abundis, MD, MSc, PhD Unidad de Investigacion Medica en Epidemiologia Clinica
  More Information

ClinicalTrials.gov Identifier: NCT00561132     History of Changes
Other Study ID Numbers: 2002/252/129
173/03/13
FP-2003/073
First Submitted: November 19, 2007
First Posted: November 20, 2007
Last Update Posted: November 20, 2007
Last Verified: November 2007

Keywords provided by Unidad de Investigacion Medica en Epidemiologia Clinica:
vanadium
insulin sensitivity
impaired glucose tolerance
triglycerides

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus
Endocrine System Diseases
Vanadyl sulfate
Insulin
Magnesium Oxide
Vanadium
Hypoglycemic Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Trace Elements
Micronutrients
Growth Substances