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NCT00561132 Clinical Trial

Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

Prediabetic State Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00561132
Other study ID # 2002/252/129
Secondary ID 173/03/13FP-2003
Status Completed
Phase Phase 3
First received November 19, 2007
Last updated November 19, 2007
Start date November 2003
Est. completion date November 2004

Study information
Verified date November 2007
Source Unidad de Investigacion Medica en Epidemiologia Clinica
Contact n/a
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vanadyl sulfate
50 mg twice daily orally for a period of 4 weeks
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

Locations
Country Name City State
Mexico Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente Guadalajara Jalisco

Sponsors (3)
Lead Sponsor Collaborator
Unidad de Investigacion Medica en Epidemiologia Clinica Doctorado en Farmacologia de la Universidad de Guadalajara, Fondo para el Fomento a la Investigacion Medica

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique 4 weeks
Secondary Changes on metabolic profile 4 weeks
Secondary Changes on anthropometrical measures 4 weeks
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