Central Mechanisms That Regulate Glucose Metabolism in Humans

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Albert Einstein College of Medicine of Yeshiva University

ClinicalTrials.gov Identifier:

NCT01028846

First received: December 7, 2009

Last updated: December 8, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2009

Last Updated Date

December 8, 2009

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01028846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Central Mechanisms That Regulate Glucose Metabolism in Humans

Official Title ^ICMJE

Central Mechanisms That Regulate Glucose Metabolism in Humans

Brief Summary

The purpose of this study is to understand how diazoxide, a medication that has been shown to have effects on insulin and other hormone secretion, can regulate the production of sugar by the liver.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Diazoxide

4mg-6mg/kg orally once before study

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

BP < 130/90 (+-2 meds)
BMI < 35
Normal screening labs (CBC, chemistry, lft's PT/PTT)
No CAD
No first degree relatives with history of CAD or MI (men < 45; women < 55)
Good IV access
Noth other medical problems with exception: HTN (on < or = 2 meds), hypercholesterolemia, and stable retinopathy
Non-smoker
Hemoglobin A1C 7.5-11

Exclusion Criteria:

BP>130/90 (+- medications)
BMI > 35
Abnormal EKG
History of CAD or exertional chest pain
First degree relative with early CAD or MI
Medications for medical or psychiatric conditions including: dofetilide, fosphenytoin/phenytoin trichlormethiazide (any thiazide), chlorpromazine and warfarin
< 4 week history of participation in another drug trial

Gender

Both

Ages

21 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marisa Morrill

718-430-2903

marisa.morrill@einstein.yu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01028846

Other Study ID Numbers ^ICMJE

2006-414

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Meredith Hawkins, Albert Einstein College of Medicine

Study Sponsor ^ICMJE

Albert Einstein College of Medicine of Yeshiva University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Meredith Hawkins, MD

Albert Einstein College of Medicine of Yeshiva University

Information Provided By

Albert Einstein College of Medicine of Yeshiva University

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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