NCT00561132

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

November 19, 2007

Last Update Submit

November 19, 2007

Conditions

Prediabetic State

Keywords

vanadiuminsulin sensitivityimpaired glucose tolerancetriglycerides

Outcome Measures

Primary Outcomes (1)

  • Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique

    4 weeks

Secondary Outcomes (2)

  • Changes on metabolic profile

    4 weeks

  • Changes on anthropometrical measures

    4 weeks

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Vanadyl sulfate

2

PLACEBO COMPARATOR
Other: Magnesium oxide

Interventions

Vanadyl sulfateDIETARY_SUPPLEMENT

50 mg twice daily orally for a period of 4 weeks

Also known as: Vanadyl sulphate, Vanadyl sulfate hydrate, Vanadyl sulphate hydrate
1
Magnesium oxideOTHER

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

Also known as: Calcinated magnesia, Calcined Magnesite, Magnesia
2

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of impaired glucose tolerance
  • Body mass index from 25 to 35 kg/m2
  • History of type 2 diabetes mellitus in the first branch

You may not qualify if:

  • Taking medication with known effects on carbohydrate or insulin metabolism
  • Thyroid diseases
  • Hepatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guadalajara, Jalisco, 44320, Mexico

Location

MeSH Terms

Conditions

Prediabetic StateInsulin ResistanceGlucose Intolerance

Interventions

vanadyl sulfateMagnesium Oxide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismHyperglycemia

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Esperanza Martínez-Abundis, MD, MSc, PhD

    Unidad de Investigacion Medica en Epidemiologia Clinica

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

November 1, 2003

Study Completion

November 1, 2004

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

ME(1)