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Matrix Metalloproteinases and Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067886
First Posted: September 1, 2003
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
  Purpose
Matrix metalloproteinases (MMPs) are a family of protein-degrading enzymes that are involved in the breakdown and remodeling of many tissues and organs. Abnormal activity of these enzymes has been implicated in many disease processes including rheumatoid arthritis, dental disease and metastatic cancer. Recent studies also suggest that elevations in blood sugar may abnormally effect MMP enzyme activity. Decreased activity of some of these MMP enzymes may be a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the start of diabetic kidney disease (nephropathy). Preliminary clinical data from our laboratory confirm that children with newly diagnosed type 1 diabetes mellitus (DM) have lower blood levels of some of these enzymes at the time of very high blood sugar readings. However, these enzyme levels become normal again as blood sugar levels improve with insulin treatment. In the present study, we propose to investigate the hypothesis that MMPs are involved in the cause of diabetic kidney disease by measuring concentrations of specific MMPs and some related proteins in the blood and urine of patients with type 1 DM who are between the ages of 14-40 years. We will enroll some patients who are recently diagnosed with diabetes, some who have had diabetes for several years, but without signs of kidney disease, and some with long-term diabetes and various degrees of kidney disease. Continuous Subcutaneous Glucose Monitoring, conducted for 3-4 days, will also be provided as a part of this study, to determine how different levels of blood sugar control might relate to different levels of MMP enzyme activity in the blood. We anticipate that this study will help to establish a link between abnormal MMP activity and the cause of nephropathy in type 1 DM, allowing scientists to design better therapies for the prevention and treatment of diabetes-related kidney problems.

Condition
Diabetes Mellitus, Type 1 Diabetic Nephropathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Matrix Metalloproteinases and Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Enrollment: 330
Study Start Date: March 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Type 1 Diabetes mellitus, ages 14-40 years.
Criteria
Type 1 Diabetes with or without kidney disease and past puberty.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067886


Locations
United States, Arkansas
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kathryn M Thrailkill, MD Arkansas Chilldren's Hospital Research Institute
  More Information

Publications:
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00067886     History of Changes
Other Study ID Numbers: DK62999
R01DK062999 ( U.S. NIH Grant/Contract )
First Submitted: August 29, 2003
First Posted: September 1, 2003
Last Update Posted: April 13, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Complications