Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

November 19, 2007 updated by: Unidad de Investigacion Medica en Epidemiologia Clinica

Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44320
        • Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • Magnesia
  • Calcined Magnesite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes on metabolic profile
Time Frame: 4 weeks
4 weeks
Changes on anthropometrical measures
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidad de Investigacion Medica en Epidemiologia Clinica

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 19, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002/252/129
  • 173/03/13
  • FP-2003/073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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