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

This study is not yet open for participant recruitment.
Verified by Vanderbilt University, August 2008

Sponsors and Collaborators: Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00600730
  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

MedlinePlus related topics:   Diabetes    Diabetes Type 1    Exercise and Physical Fitness    Hypoglycemia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia

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
Study Start Date:   January 2009
Estimated Study Completion Date:   April 2010
Estimated Primary Completion Date:   April 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Hyperinsulinemic euglycemic clamp with fMRi
Procedure: Hyperinsulinemic euglycemic clamp with fMRi
Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
2: Experimental
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

Contacts
Contact: Donna Tate, MS     615-936-1824     donna.tate@vanderbilt.edu    

Sponsors and Collaborators

Investigators
Principal Investigator:     Stephen N Davis, MD     Vanderbilt University    
  More Information


Responsible Party:   Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:   IRB#040025-Brain and Hypo, RO1DK069803-03
First Received:   January 14, 2008
Last Updated:   October 21, 2008
ClinicalTrials.gov Identifier:   NCT00600730
Health Authority:   United States: Institutional Review Board

Keywords provided by Vanderbilt University:
fMRi  
hypoglycemia  

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 28, 2008




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