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

This study has been withdrawn prior to enrollment.
(Funding not available. Could not start this study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600730
First Posted: January 25, 2008
Last Update Posted: June 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University
  Purpose
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

Condition Intervention
Type 1 Diabetes Procedure: Hyperinsulinemic euglycemic clamp with fMRi Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Steve Davis, Vanderbilt University:

Primary Outcome Measures:
  • fMRi scans [ Time Frame: 1 day ]

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
Hyperinsulinemic euglycemic clamp with fMRi
Procedure: Hyperinsulinemic euglycemic clamp with fMRi
Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
Experimental: 2
Hyperinsulinemic hypoglycemic clamp with fMRI
Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi
Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600730


Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stephen N Davis, MD Vanderbilt University
  More Information

Responsible Party: Steve Davis, Chairman of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00600730     History of Changes
Other Study ID Numbers: IRB#040025-Brain and Hypo
R01DK069803-03 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2008
First Posted: January 25, 2008
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Steve Davis, Vanderbilt University:
fMRi
hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs