NCT00279240

Brief Summary

Three year prospective randomised controlled trial in IGT subjects to study the effect of metformin and lifestyle modification in preventing the conversion to diabetes

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_1 diabetes

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

March 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
Last Updated

January 24, 2006

Status Verified

July 1, 2002

First QC Date

January 18, 2006

Last Update Submit

January 23, 2006

Conditions

Diabetes

Keywords

Impaired glucose toleranceInterventionPrevention

Outcome Measures

Primary Outcomes (1)

  • Reduction in conversion of IGT to diabetes

Secondary Outcomes (1)

  • Benefits of the drug on anthropometric variables and biochemical parameters

Interventions

MetforminDRUG

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female. 35 - 55 years. No Known history of diabetes. Willing and available for a three years study.

You may not qualify if:

  • Pregnant women. Subjects with major illness such as cancer, hepatic or cardiac diseases. Tranferable jobs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Centre & MV Hospital for Diabetes

Chennai, Tamil Nadu, 600013, India

Location

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Ambady Ramachandran, MD,PhD,DSc.

    Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 19, 2006

Study Start

March 1, 2001

Study Completion

December 1, 2004

Last Updated

January 24, 2006

Record last verified: 2002-07

Locations

IN(1)