CClinicalTrials.gg
WithdrawnNCT00608816Updated Dec 11, 2014

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

An interventional study of epinephrine and epinephrine in Type 1 Diabetes, sponsored by Vanderbilt University. Withdrawn. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-11.

Sponsored by Vanderbilt University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Read the detailed description

When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened. This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences. Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • epinephrine
03

In context

Pure Autonomic Failure

56 studies on the registry are indexed under Pure Autonomic Failure; 11 are open to participants now.

Browse Pure Autonomic Failure studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C > 8.5%
  • 28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C \< 7%
  • 28 (14 males, 14 females) non-diabetic controls
  • Age 18-45 yr.
  • Had diabetes for 2-15 years if diabetic subject
  • No clinical evidence of diabetic tissue complications, no cardiovascular disease
  • Body mass index 21-27kg · m-2
  • Normal bedside autonomic function
  • Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
  • Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion criteria

Exclusion Criteria:

  • Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
  • Hemoglobin of less than 12 g/dl
  • Abnormal results following screening tests
  • Pregnancy
  • Subjects unable to give voluntary informed consent
  • Subjects with a recent medical illness
  • Subjects with known liver or kidney disease
  • Subjects taking steroids
  • Subjects taking beta blockers
  • Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Hyperinsulinemic euglycemic glucose clamp study on day 1 Hyperinsulinemic euglycemic clamp study on day 2 with epinephrine infusion

    Drug: epinephrine

  • Experimental
    2

    Hyperinsulinemic hypoglycemic glucose clamp x 2 on day 1 Hyperinsulinemic euglycemic clamp with epinephrine infusion on Day 2

    Drug: epinephrine

Interventions

  • Drugepinephrine

    Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2

  • Drugepinephrine

    Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2

06

What researchers measure

Primary outcomes

  1. catecholamine levels

    Time frame: 2 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00608816
Lead sponsor
Vanderbilt University
Responsible party
Steve Davis (Chairman of Medicine, University of Maryland, Baltimore, Vanderbilt University) — Principal investigator
First posted
Feb 6, 2008
Last update
Dec 11, 2014

Study contacts

Stephen N. Davis, MD
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion