Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

NCT00592332 | Completed

• 2 other identifiers: IRB#040908-HAAF-T1DM-Q2DK69803
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Catecholamine levels

  Comparative study performed every 6-8 weeks

Study Arms (2)

2

EXPERIMENTAL

Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.

Drug: Alprazolam

1

EXPERIMENTAL

Hyperinsulinemic glucose clamp in group with no drug.

Other: control group

Interventions

Alprazolam DRUG

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

Also known as: Xanax

2

control group OTHER

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

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Alprazolam; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Stephen N Davis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Study Record Dates

• First Submitted: January 1, 2008
• First Posted: January 14, 2008
• Study Start: June 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2009
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)