Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00561132
First received: November 19, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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 Blind (Subject, 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on September 18, 2014