Clinical trial NCT00943787: Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
Official title: Counter-regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Maximum Epinephrine Response (LBGI Groups)
timeFrame: 285 min (time of clamp)
Secondary outcomes:
measure: Maximum Epinephrine Response (ADRR Groups)
timeFrame: 285 min (time of clamp)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System - Behavioral Medicine Center
state: Virginia
Study officials:
affiliation: University of Virginia Health Systems - Behavioral Medicine Center
name: Boris Kovatchev, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitsillides AN, Anderson SM, Kovatchev B. Hypoglycemia risk and glucose variability indices derived from routine self-monitoring of blood glucose are related to laboratory measures of insulin sensitivity and epinephrine counterregulation. Diabetes Technol Ther. 2011 Jan;13(1):11-7. doi: 10.1089/dia.2010.0103.
citation: Chan A, Barrett EJ, Anderson SM, Kovatchev BP, Breton MD. Muscle microvascular recruitment predicts insulin sensitivity in middle-aged patients with type 1 diabetes mellitus. Diabetologia. 2012 Mar;55(3):729-36. doi: 10.1007/s00125-011-2402-3. Epub 2011 Dec 14.