NCT03566511|TerminatedPhase 2ResultsDMCFDA Drug
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Grant funding ended. NIDDK grant renewed without an MR aim. No plans to do future studies.
Sponsor study identifier
Secondary identifiers
NIH
interventional
37
1 country
1
Study Start
June 12, 2018
Actual (reported)Primary Completion
August 1, 2020
Actual (reported)Study Completion
August 1, 2020
Actual (reported)The goal of this study is to determine whether metabolic control centers in the brain can be activated in patients with type 2 diabetes (T2D) as compared to non-diabetic individuals. This is important since people with diabetes have inappropriately high production of glucose, which could be at least in part due to impaired activation of important brain centers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2018
Actual (reported)June 12, 2018
Actual (reported)June 25, 2018
Actual (reported)August 1, 2020
Actual (reported)August 1, 2020
Actual (reported)May 31, 2025
Actual (reported)Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing
Arterial Spin Labeling data was acquired and converted by the Gruss Magnetic Resonance Research Center (MRRC) and reported as Hypothalamic Cerebral Blood Flow (CBF) which is a more meaningful clinical endpoint measurement. Data was collected at three time points during each of the two study visits (pre dosing, 2 hours post dosing, and 5 hours post dosing). CBF values at the respective timepoints are summarized in mL/100g/min units and reported by study arm. An increase in CBF is correlated with an increase in brain activity.
2 hours and 5 hours post dosing
Proglycem, oral suspension (4-7 mg/kg). Healthy participants will receive diazoxide between MRI scans.
Taste-matched placebo. Healthy participants will receive placebo between MRI scans.
Proglycem, oral suspension (4-7 mg/kg). Type 2 diabetic (T2D) participants will receive diazoxide between MRI scans.
Healthy and T2D participants will receive diazoxide at a dose of 4-7 mg/kg (based upon weight) between baseline MRI scan and second MRI scan.
Healthy and T2D participants will receive placebo between baseline MRI scan and second MRI scan.
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Instrumentation got remodeled and further studies were unable to be conducted and the trial was unable to be completed as proposed.
Meredith Hawkins, M.D., M.S.
Albert Einstein College of Medicine
37 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2018
First Posted
June 25, 2018
A Phase 2 Study of Cyclo-Z in Subjects With Type 2 Diabetes
Taste-matched placebo. T2D participants will receive placebo between MRI scans.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
June 12, 2018
Actual (reported)Primary Completion
August 1, 2020
Actual (reported)Study Completion
August 1, 2020
Actual (reported)Last Updated
May 31, 2025
Results First Posted
May 31, 2025
Record last verified: 2025-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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