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

NCT00600730 | Withdrawn

• 2 other identifiers: IRB#040025-Brain and HypoR01DK069803-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

fMRi; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• fMRi scans

  1 day

Study Arms (2)

1

EXPERIMENTAL

Hyperinsulinemic euglycemic clamp with fMRi

Procedure: Hyperinsulinemic euglycemic clamp with fMRi

2

EXPERIMENTAL

Hyperinsulinemic hypoglycemic clamp with fMRI

Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi

Interventions

Hyperinsulinemic euglycemic clamp with fMRi PROCEDURE

Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi

1

Hyperinsulinemic hypoglycemic clamp study with fMRi PROCEDURE

Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stephen N Davis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Medicine

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Last Updated: June 10, 2015

Record last verified: 2015-06