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Central Mechanisms That Regulate Glucose Metabolism in Humans

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Meredith Hawkins, Albert Einstein College of Medicine, Inc.
Sponsor:
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT01028846
First received: December 7, 2009
Last updated: June 28, 2017
Last verified: June 2017
  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

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
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
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
Study First Received: December 7, 2009
Last Updated: June 28, 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

ClinicalTrials.gov processed this record on August 22, 2017