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Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

NCT ID: NCT00561132

Last Updated: 2007-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetic State

Keywords

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vanadium insulin sensitivity impaired glucose tolerance triglycerides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Vanadyl sulfate

Intervention Type DIETARY_SUPPLEMENT

50 mg twice daily orally for a period of 4 weeks

2

Group Type PLACEBO_COMPARATOR

Magnesium oxide

Intervention Type OTHER

Validation of similar appearance and weight to the intervention component orally 1 unit (\<50 mg) twice daily for a period of 4 weeks

Interventions

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Vanadyl sulfate

50 mg twice daily orally for a period of 4 weeks

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Other Intervention Names

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Vanadyl sulphate Vanadyl sulfate hydrate Vanadyl sulphate hydrate Calcinated magnesia Calcined Magnesite Magnesia

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondo para el Fomento a la Investigacion Medica

UNKNOWN

Sponsor Role collaborator

Doctorado en Farmacologia de la Universidad de Guadalajara

UNKNOWN

Sponsor Role collaborator

Unidad de Investigacion Medica en Epidemiologia Clinica

OTHER

Sponsor Role lead

Principal Investigators

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Omar Jacques-Camarena, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Unidad de Investigacion Medica en Epidemiologia Clinica

Manuel González-Ortiz, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Investigacion Medica en Epidemiologia Clinica

Esperanza Martínez-Abundis, MD, MSc, PhD

Role: STUDY_DIRECTOR

Unidad de Investigacion Medica en Epidemiologia Clinica

Locations

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Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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173/03/13

Identifier Type: -

Identifier Source: secondary_id

FP-2003/073

Identifier Type: -

Identifier Source: secondary_id

2002/252/129

Identifier Type: -

Identifier Source: org_study_id