Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

This study has been completed.

Sponsors and Collaborators:	Unidad de Investigacion Medica en Epidemiologia Clinica Fondo para el Fomento a la Investigacion Medica Universidad de Guadalajara
Information provided by:	Unidad de Investigacion Medica en Epidemiologia Clinica
ClinicalTrials.gov Identifier:	NCT00561132

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 III

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Insulin Magnesium Dextrose Magnesium oxide Vanadium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

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
1: Experimental	Dietary Supplement: Vanadyl sulfate 50 mg twice daily orally for a period of 4 weeks
2: Placebo Comparator	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

Eligibility

Ages Eligible for Study:	40 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561132

Locations

Mexico, Jalisco
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

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

Study ID Numbers:	2002/252/129, 173/03/13, FP-2003/073
Study First Received:	November 19, 2007
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00561132
Health Authority:	Mexico: Ministry of Health

Keywords provided by Unidad de Investigacion Medica en Epidemiologia Clinica:

vanadium
insulin sensitivity
impaired glucose tolerance
triglycerides

Study placed in the following topic categories:

Vanadium
Metabolic Diseases
Magnesium Oxide
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases

Insulin
Hyperglycemia
Vanadyl sulfate
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs

Trace Elements
Antacids
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009