N/A
N=41
Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00943787 ↗Enrolled (actual)
41
Serious AEs
8.8%
Results posted
Sep 2014
Primary outcome: Primary: Maximum Epinephrine Response (LBGI Groups) — 495; 217 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyperinsulinemic, euglycemic and hypoglycemic clamp (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Epinephrine Response (LBGI Groups) |
495; 217 | — |
| SECONDARY Maximum Epinephrine Response (ADRR Groups) |
417; 167 | — |
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 50%)
- History of an ischemic cerebrovascular event
- Active substance abuse
- Psychosis
- Mental retardation
- Severe depression
Data sourced from ClinicalTrials.gov (NCT00943787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.