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Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus (BPK003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00943787
First received: June 24, 2009
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

The researchers plan to test the following hypothesis:

A good level of glucose control in Type 1 Diabetes Mellitus (T1DM) is dependent on two levels of feedback from the body:

  1. the transport of insulin through small blood vessels: suggesting that hypoglycemia leads to increased insulin sensitivity which then causes recurrent hypoglycemia;
  2. the endocrine level, defined as insulin-glucose interaction and hormonal counter-regulation.

The researchers plan to investigate the relationships between hypoglycemia, insulin transport, and counter-regulation. This study will ultimately lead to a better understanding of risk for recurrent hypoglycemia.


Condition
Diabetes Mellitus, Type 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Counter-regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

plasma glucose, insulin, and counterregulatory hormone assays


Enrollment: 44
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with type 1 diabetes

Criteria

Inclusion Criteria:

  • Participated in and satisfied all of the inclusion criteria of NCT00315939
  • 18 years of age or older
  • Have Type 1 Diabetes Mellitus defined by American Diabetes Association criteria or judgment of physician
  • Since our major goal is the investigation of hypoglycemia, we will preferentially recruit patients with a history of severe hypoglycemia/moderate hypoglycemia anticipating that approximately (~) half of the recruited subjects will have had two or more severe or moderate hypoglycemia episodes in the past 12 months

Exclusion Criteria:

  • Age < 18
  • Pregnancy
  • Use of oral steroids
  • Hematocrit < 36% (females); < 38% (males)
  • Symptomatic heart disease (e.g., history of myocardial infarction, history of coronary bypass or stenting procedure, angina, episode of chest pain of cardiac etiology with documented EKG changes, positive stress test or catheterization with coronary blockages > 50%)
  • History of an ischemic cerebrovascular event
  • Active substance abuse
  • Psychosis
  • Mental retardation
  • Severe depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943787

Locations
United States, Virginia
University of Virginia Health System - Behavioral Medicine Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Boris Kovatchev, Ph.D. University of Virginia Health Systems - Behavioral Medicine Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boris Kovatchev, PhD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT00943787     History of Changes
Other Study ID Numbers: 12252
Study First Received: June 24, 2009
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013