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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy individuals aged 18-50 years
  • Type 1 Diabetes individuals aged 18-50 years
  • BMI <40 kg/m2
  • Females of childbearing potential with negative urine pregnancy test
  • Volunteers over 40 years of age, a cardiac stress test with no clinically significant conduction or ischemic changes

Exclusion Criteria:

The following groups of subjects will be excluded from the study:

  • Pregnant women
  • Subjects unable to give voluntary informed consent
  • Subjects on anticoagulant drugs or with known bleeding diatheses
  • Subjects with uncontrolled hypertension, heart disease, cerebrovascular incidents
  • Subjects taking MAOIs
  • Subjects with narrow angle glaucoma
  • Subjects with diagnosed psychiatric disorders
  • Subjects with allergy to atomoxetine, heparin, or lidocaine

Physical Exam Exclusion Criteria:

  • Uncontrolled severe hypertension (i.e., blood pressure greater than 150/95)
  • Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects > 40 years old.
  • Pneumonia
  • Hepatic Failure/Jaundice
  • Renal Failure
  • Acute Cerebrovascular/ Neurological deficit
  • Fever greater than 38.0 C

Screening Laboratory Tests Exclusion Criteria Blood values as defined in protocol

Sites / Locations

  • Univerisity of Maryland, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change in level of catecholamines in blood from baseline

Secondary Outcome Measures

Full Information

First Posted
October 24, 2008
Last Updated
September 10, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00780650
Brief Title
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Official Title
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself against low blood sugar.
Detailed Description
The purpose of this study is to see if the drug atomoxetine (Strattera) has effects on the body's ability to defend itself against low blood sugar. Normally, when blood sugar levels drop below normal, the body creates a series of responses, which increase the sugar inside the body to bring blood sugar levels back to normal. The hormone epinephrine is a key defense against low blood sugar in people with diabetes. Atomoxetine has been shown to increase this hormone level. Thus, any approaches to increase levels of this key defense during low blood sugar may have great value.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
80 mg oral dose, once per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
80 mg dose once per day for 6 weeks
Primary Outcome Measure Information:
Title
Change in level of catecholamines in blood from baseline
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals aged 18-50 years Type 1 Diabetes individuals aged 18-50 years BMI <40 kg/m2 Females of childbearing potential with negative urine pregnancy test Volunteers over 40 years of age, a cardiac stress test with no clinically significant conduction or ischemic changes Exclusion Criteria: The following groups of subjects will be excluded from the study: Pregnant women Subjects unable to give voluntary informed consent Subjects on anticoagulant drugs or with known bleeding diatheses Subjects with uncontrolled hypertension, heart disease, cerebrovascular incidents Subjects taking MAOIs Subjects with narrow angle glaucoma Subjects with diagnosed psychiatric disorders Subjects with allergy to atomoxetine, heparin, or lidocaine Physical Exam Exclusion Criteria: Uncontrolled severe hypertension (i.e., blood pressure greater than 150/95) Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects > 40 years old. Pneumonia Hepatic Failure/Jaundice Renal Failure Acute Cerebrovascular/ Neurological deficit Fever greater than 38.0 C Screening Laboratory Tests Exclusion Criteria Blood values as defined in protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen N. Davis, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univerisity of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

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