Mechanisms of Hypoglycemia Associated Autonomic Dysfuncti... | NCT00780650

Studies
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

NCT00780650

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

56Actual

Phase

Early Phase 1

Conditions

Type 1 Diabetes

Interventions

Atomoxetine
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Aug 21, 2018Actual

Completion Date

Aug 21, 2018Actual

First Submitted Date

Oct 24, 2008

First Submission Date that Met QC Criteria

Oct 24, 2008

First Posted Date

Oct 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: Atomoxetine
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine	Drug	80 mg oral dose, once per day for 6 weeks	1	Strattera

Measure	Description	Time Frame
Change in level of catecholamines in blood from baseline		6 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals