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The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia

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Vanderbilt University

Status

Withdrawn

Conditions

Type 1 Diabetes

Treatments

Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi
Procedure: Hyperinsulinemic euglycemic clamp with fMRi

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00600730
IRB#040025-Brain and Hypo
R01DK069803-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

Full description

The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and female subjects aged 18-45
  • Type 1 diabetes mellitus patients aged 18-45
  • Body Mass Index 21-38 kg/m2
  • Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an EKG stress test.
  • Female volunteers of childbearing potential will undergo HCG pregnancy test. Only women who are not pregnant will participate in the study.

Diabetic Subjects:

  • HBA1C= 5.5-11.0%
  • Duration of Type 1 Diabetes > 3 yr
  • Normal bedside autonomic function

Exclusion criteria

All Subjects

  • Prior or current history of poor health
  • Abnormal results following screening tests
  • Pregnancy
  • Subjects unable to give voluntary informed consent
  • Subjects with a recent medical illness
  • Subjects with a history of hypertension, heart disease or cerebrovascular disease
  • Subjects with known liver or kidney disease
  • Subjects with recent weight loss or consuming a low carbohydrate diet
  • Subjects taking steroids
  • Subjects taking beta-blockers
  • Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
  • Evidence of diabetic neuropathy, autonomic neuropathy, proteinuria, extensive background or proliferative retinopathy, hypertension, or cardiovascular disease

Trial design

0 participants in 2 patient groups

1
Experimental group
Description:
Hyperinsulinemic euglycemic clamp with fMRi
Treatment:
Procedure: Hyperinsulinemic euglycemic clamp with fMRi
2
Experimental group
Description:
Hyperinsulinemic hypoglycemic clamp with fMRI
Treatment:
Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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