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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This study has been withdrawn prior to enrollment.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:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00600730
First received: January 14, 2008
Last updated: June 23, 2009
Last verified: June 2009
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • fMRi scans [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600730

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

No publications provided

Responsible Party: Stephen N. Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00600730     History of Changes
Other Study ID Numbers: IRB#040025-Brain and Hypo, RO1DK069803-03
Study First Received: January 14, 2008
Last Updated: June 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013