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

University of Virginia

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Procedure: Hyperinsulinemic, euglycemic and hypoglycemic clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT00943787

12252

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 1 patient group

SMBG followed by clamp

Other group

Description:

One month of self-monitored blood glucose (SMBG) field data was used to calculate measures of glucose variability and risk of hypoglycemia, while the hyperinsulinemic, euglycemic and hypoglycemic clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.

Treatment:

Procedure: Hyperinsulinemic, euglycemic and hypoglycemic clamp