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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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Diazoxide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Central Mechanisms That Regulate Glucose Metabolism in Humans

Resource links provided by NLM:

Drug Information available for: Diazoxide
U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Diazoxide
    4mg-6mg/kg orally once before study
  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028846

Contacts
Contact: Marisa Morrill 718-430-2903 marisa.morrill@einstein.yu.edu

Locations
United States, New York
Albert Einstein College of Medicine of Yeshiva University Recruiting
Bronx, New York, United States, 10461
Principal Investigator: Meredith Hawkins, MD            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Meredith Hawkins, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Dr. Meredith Hawkins, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01028846     History of Changes
Other Study ID Numbers: 2006-414
Study First Received: December 7, 2009
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diazoxide
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013