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

June 24, 2009
September 14, 2011
January 2006
May 2009   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00943787 on ClinicalTrials.gov Archive Site
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Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
Counter-regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus

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.

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Observational
Observational Model: Case-Only
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Retention:   None Retained
Description:

plasma glucose, insulin, and counterregulatory hormone assays

Non-Probability Sample

Adults with type 1 diabetes

Diabetes Mellitus, Type 1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943787
12252
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Boris Kovatchev, PhD, University of Virginia
University of Virginia
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Principal Investigator: Boris Kovatchev, Ph.D. University of Virginia Health Systems - Behavioral Medicine Center
University of Virginia
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP