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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
  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:


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

Primary Outcome Measures:
  • Endogenous Glucose Production [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose Uptake [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Diazoxide 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Morgan Drucker, BS Morgan.drucker@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: Meredith Hawkins, Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01028846     History of Changes
Other Study ID Numbers: 2006-414
Study First Received: December 7, 2009
Last Updated: July 10, 2014
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, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Diazoxide
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014