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

NCT ID: NCT00600730

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Hyperinsulinemic euglycemic clamp with fMRi

Group Type: EXPERIMENTAL

Hyperinsulinemic euglycemic clamp with fMRi

Intervention Type: PROCEDURE

Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi

2

Hyperinsulinemic hypoglycemic clamp with fMRI

Group Type: EXPERIMENTAL

Hyperinsulinemic hypoglycemic clamp study with fMRi

Intervention Type: PROCEDURE

Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning

Interventions

Hyperinsulinemic euglycemic clamp with fMRi

Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi

Intervention Type: PROCEDURE

Hyperinsulinemic hypoglycemic clamp study with fMRi

Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Steve Davis

Chairman of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen N Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Other Identifiers

R01DK069803-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#040025-Brain and Hypo

Identifier Type: -

Identifier Source: org_study_id