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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 14, 2008

Last Updated Date

March 4, 2009

Start Date ^†

January 2009

Current Primary Outcome Measures ^†

fMRi scans [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600730 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^†

Type 1 Diabetes

Intervention ^†

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

Study Arms / Comparison Groups

Experimental: Hyperinsulinemic euglycemic clamp with fMRi
Experimental: Hyperinsulinemic hypoglycemic clamp with fMRI

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Withdrawn

Estimated Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600730

Responsible Party

Stephen N. Davis, MD, Vanderbilt University

Secondary IDs ^††

RO1DK069803-03

Study Sponsor ^†

Vanderbilt University

Collaborators ^††

National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^†

Principal Investigator:

Stephen N Davis, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.