Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03540758 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Regulation of Endogenous Glucose Production by Central KATP Channels

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Meredith Hawkins to Albert Einstein College of Medicinev17 Show 4 more changesShow less
    • Eligibility criteria expanded, about 71 words
    • Study description shortened, about 206 words
    • Collaborators: 3 to 5
    • Study arms: 8 to 4
  2. Lead sponsor: Albert Einstein College of Medicine to Meredith Hawkinsv16
  3. Enrollment target: 60 to 100v15 Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 369 words
    • Study description expanded, about 340 words
    • Collaborators: 2 to 3
    • Study arms: 6 to 8
  4. Enrollment target: 30 to 60
    • Primary and study completion dates: Apr 30, 2027 to Apr 2027
    v14
  5. Enrollment target: 60 to 30v13
Show 11 earlier versionsHide 11 earlier versions
  1. Enrollment target: 30 to 60v12
  2. Enrollment target: 1 to 30v11
  3. Enrollment target: 45 to 1v10
  4. Trial status: Suspended to Recruiting
    • Primary and study completion dates: Apr 2022 to Apr 30, 2027
    • Site details revised
    v9
  5. Primary completion date: Apr 2021 to Apr 2022
    • Eligibility criteria shortened, about 7 words
    v8
  6. Trial status: Recruiting to Suspended Sponsor's reason: Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.
    • Primary completion date: Dec 2020 to Apr 2021
    • Study completion date: Dec 2021 to Apr 2022
    • Site details revised
    v7
  7. Primary completion date: Nov 2020 to Dec 2020
    • Study completion date: Nov 2021 to Dec 2021
    • Eligibility criteria expanded, about 2 words
    v6
  8. Re-verified, no change to tracked fieldsv5
  9. Eligibility criteria expanded, about 18 words
    • Study description expanded, about 61 words
    • Site contact updated
    v4
  10. Start date changed from estimate of Jun 2018 to Aug 1, 2018
    • Site contact updated
    v3
  11. Study description expanded, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.
Trial Details
NCT Number NCT03540758
Lead Sponsor Albert Einstein College of Medicine
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association, Rutgers University, Vanderbilt University Medical Center
Conditions
(from sponsor)		 Diabetes Mellitus, Glucose Metabolism Disorders
Related terms Diabetes Mellitus, Glucose Metabolism Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov