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Central Mechanisms That Regulate Glucose Metabolism in Humans

This study is currently recruiting participants.
Verified June 2017 by Meredith Hawkins, Albert Einstein College of Medicine, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028846
First Posted: December 9, 2009
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine, Inc.
  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 Drug: Glyburide Device: Vagal Nerve Stimulator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Meredith Hawkins, Albert Einstein College of Medicine, Inc.:

Primary Outcome Measures:
  • Endogenous Glucose Production [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • Glucose Uptake [ Time Frame: 4 hours ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diazoxide Drug: Diazoxide
4mg-6mg/kg orally once before study
Active Comparator: Glyburide Drug: Glyburide
Administered orally at beginning of study
Active Comparator: Vagal Nerve Stimulator Device: Vagal Nerve Stimulator
Device approved for the purpose of decreasing seizure frequency in patients with poorly-controlled epilepsy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
The Bronx, New York, United States, 10461
Principal Investigator: Meredith Hawkins, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Meredith Hawkins, MD Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Meredith Hawkins, Professor, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01028846     History of Changes
Other Study ID Numbers: 2006-414
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: June 29, 2017
Last Verified: June 2017

Keywords provided by Meredith Hawkins, Albert Einstein College of Medicine, Inc.:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Diazoxide
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents