Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Type 1 Diabetes Clinical Trial

Official title:

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592332
• Other study ID #: IRB#040908-HAAF-T1DM-Q2
• Secondary ID: DK69803
• Status: Completed
• Phase: N/A
• First received: January 1, 2008
• Last updated: December 10, 2014
• Start date: June 2005
• Est. completion date: June 2009

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.

Description:

Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior activation of GABA(A) receptors may result in blunting of counterregulatory responses during next day hypoglycemia.

The Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms during next day hypoglycemia in T1DM and healthy man.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.

• 16 (8 males, 8 females) healthy controls aged 18-45 yr.

• HbA1c > 7.0% (Type 1 diabetes patients)

• Had diabetes for 2-15 years (Type 1 diabetes patients)

• No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)

• Body mass index 21-30 kg · m-2

• Normal bedside autonomic function

• Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities

• Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

• Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease

• Hemoglobin of less than 12 g/dl

• Abnormal results following screening tests

• Pregnancy

• Subjects unable to give voluntary informed consent

• Subjects with known liver or kidney disease

• Subjects taking steroids

• Subjects taking beta blockers

• Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hypoglycemia
• Pure Autonomic Failure
• Type 1 Diabetes

Intervention

Drug:
• Alprazolam
1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)

Other:
• control group
control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catecholamine levels		Comparative study performed every 6-8 weeks	No