Central Mechanisms That Regulate Glucose Metabolism in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01028846
First received: December 7, 2009
Last updated: July 10, 2014
Last verified: July 2014

December 7, 2009
July 10, 2014
May 2011
September 2014   (final data collection date for primary outcome measure)
Endogenous Glucose Production [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01028846 on ClinicalTrials.gov Archive Site
Glucose Uptake [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Central Mechanisms That Regulate Glucose Metabolism in Humans
Central Mechanisms That Regulate Glucose Metabolism in Humans

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Diazoxide
4mg-6mg/kg orally once before study
Placebo Comparator: Diazoxide
Intervention: Drug: Diazoxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 60 Years
No
Contact: Morgan Drucker, BS Morgan.drucker@einstein.yu.edu
United States
 
NCT01028846
2006-414
Yes
Meredith Hawkins, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
Not Provided
Principal Investigator: Meredith Hawkins, MD Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
July 2014

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