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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00600730
• Other study ID #: IRB#040025-Brain and Hypo
• Secondary ID: RO1DK069803-03
• Status: Withdrawn
• Phase: N/A
• First received: January 14, 2008
• Last updated: June 9, 2015

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypoglycemia
• Type 1 Diabetes

Intervention

Procedure:
• Hyperinsulinemic euglycemic clamp with fMRi
Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
• Hyperinsulinemic hypoglycemic clamp study with fMRi
Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRi scans		1 day	No