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Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

Primary Purpose

Prediabetic State

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Vanadyl sulfate
Magnesium oxide
Sponsored by
Unidad de Investigacion Medica en Epidemiologia Clinica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetic State focused on measuring vanadium, insulin sensitivity, impaired glucose tolerance, triglycerides

Eligibility Criteria

40 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes on metabolic profile
Changes on anthropometrical measures

Full Information

First Posted
November 19, 2007
Last Updated
November 19, 2007
Sponsor
Unidad de Investigacion Medica en Epidemiologia Clinica
Collaborators
Fondo para el Fomento a la Investigacion Medica, Doctorado en Farmacologia de la Universidad de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT00561132
Brief Title
Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance
Official Title
Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Unidad de Investigacion Medica en Epidemiologia Clinica
Collaborators
Fondo para el Fomento a la Investigacion Medica, Doctorado en Farmacologia de la Universidad de Guadalajara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
vanadium, insulin sensitivity, impaired glucose tolerance, triglycerides

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vanadyl sulfate
Other Intervention Name(s)
Vanadyl sulphate, Vanadyl sulfate hydrate, Vanadyl sulphate hydrate
Intervention Description
50 mg twice daily orally for a period of 4 weeks
Intervention Type
Other
Intervention Name(s)
Magnesium oxide
Other Intervention Name(s)
Calcinated magnesia, Calcined Magnesite, Magnesia
Intervention Description
Validation of similar appearance and weight to the intervention component orally 1 unit (<50 mg) twice daily for a period of 4 weeks
Primary Outcome Measure Information:
Title
Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes on metabolic profile
Time Frame
4 weeks
Title
Changes on anthropometrical measures
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Jacques-Camarena, MD, MSc
Organizational Affiliation
Unidad de Investigacion Medica en Epidemiologia Clinica
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel González-Ortiz, MD, MSc, PhD
Organizational Affiliation
Unidad de Investigacion Medica en Epidemiologia Clinica
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez-Abundis, MD, MSc, PhD
Organizational Affiliation
Unidad de Investigacion Medica en Epidemiologia Clinica
Official's Role
Study Director
Facility Information:
Facility Name
Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44320
Country
Mexico

12. IPD Sharing Statement

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Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance

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