NCT00018122

Brief Summary

This grant is to study patients that have received a kidney transplant AND an Islet Cell transplant and to discover how the transplant is functioning. We will seek to have several patients who have had a kidney transplant but do NOT have either type of diabetes. These patients will serve as the "control group" since they will also be on immunosuppressive medications but are not affected by abnormal blood sugars. This will allow investigators to develop an understanding of how these immunosuppressive medications affect glucose metabolism (blood sugar levels) and insulin utilization (how the body uses insulin).

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

July 3, 2001

Last Update Submit

June 27, 2005

Conditions

Diabetes Mellitus

Keywords

Islet cell transplant

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Type 1 diabetics that have received a kidney transplant as well as (under Project 1) Islet Cell Transplant. A control group of 8 kidney transplant recipients who do not have diabetes will also be sought. Age range for both groups is expected to fall in the 25-50 year/old range based upon statistical data, although those between the ages of 18 and 65 may also qualify.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)