Trial · NCT03566511

Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide

NCT03566511, Phase 2, Terminated, Meredith Hawkins; results first posted 2025-05-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide. Trials, record NCT03566511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03566511

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide
NCT number: NCT03566511
Status: Terminated
Phases: Phase 2
Enrollment: 37 participants, actual
Lead sponsor: Meredith Hawkins
Conditions: Diabetes Mellitus, Type 2, Glucose, High Blood, Glucose Metabolism Disorders (Including Diabetes Mellitus)
Interventions: Diazoxide, Placebo
First posted: 2018-06-25
Last updated: 2025-05-31
Results first posted: 2025-05-31
Limitations and caveats: Instrumentation got remodeled and further studies were unable to be conducted and the trial was unable to be completed as proposed.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	2 hours and 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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	2 hours and 5 hours post dosing	7 patients were able to complete both studies within the crossover design as described in the 'Participant Flow' module and have their data analyzed. An additional 4 patients (3 healthy, and 1 T2D) were not able to complete their measurements and, therefore, no data are available for these patients. Standard error (SE) data for the DZX studies were derived from visual estimates of the bar graphs. SE data for the Placebo studies were extrapolated from DZX studies.	mL/100g/min	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	Diazoxide	Baseline	29.78	Standard Error 1.3	mL/100g/min
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	Matched Placebo	Baseline	28.36	Standard Error 1.3	mL/100g/min
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	Diazoxide	2 hours	26.52	Standard Error 1.7	mL/100g/min
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	Matched Placebo	2 hours	26.25	Standard Error 2.0	mL/100g/min
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	Diazoxide	5 hours	28.88	Standard Error 1.4	mL/100g/min
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing	Matched Placebo	5 hours	27.75	Standard Error 1.4	mL/100g/min

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
1st Intervention (1 Day)	STARTED	Diazoxide First Then Matched Placebo	4
1st Intervention (1 Day)	STARTED	Matched Placebo First Then Diazoxide	4
1st Intervention (1 Day)	COMPLETED	Diazoxide First Then Matched Placebo	3
1st Intervention (1 Day)	COMPLETED	Matched Placebo First Then Diazoxide	4
1st Intervention (1 Day)	NOT COMPLETED	Diazoxide First Then Matched Placebo	1
1st Intervention (1 Day)	NOT COMPLETED	Matched Placebo First Then Diazoxide	0
Washout (~1 Month)	STARTED	Diazoxide First Then Matched Placebo	3
Washout (~1 Month)	STARTED	Matched Placebo First Then Diazoxide	4
Washout (~1 Month)	COMPLETED	Diazoxide First Then Matched Placebo	3
Washout (~1 Month)	COMPLETED	Matched Placebo First Then Diazoxide	4

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Uncomfortable	General disorders	Diazoxide	0	7
other	Uncomfortable	General disorders	Matched Placebo	1	7

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Diazoxide	0	7
Total, all-cause mortality	Matched Placebo	0	7
Total, other adverse events	Diazoxide	0	7
Total, other adverse events	Matched Placebo	1	7
Total, serious adverse events	Diazoxide	0	7
Total, serious adverse events	Matched Placebo	0	7

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK069861	Restoring Central Regulation of Glucose Production in Type 2 Diabetes	HAWKINS, MEREDITH A; ROUTH, VANESSA H	ALBERT EINSTEIN COLLEGE OF MEDICINE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Diazoxide vs Matched Placebo: deaths from any cause	Trial comparisons
Diazoxide vs Matched Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03566511

GET https://conductscience.org/api/trials/v1/NCT03566511/registered

API reference For AI assistants