TerminatedPhase 2

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

Stopped: Grant funding ended. NIDDK grant renewed without an MR aim. No plans to do future studies.

United States37 participantsStarted 2018-06-12

Plain-language summary

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.

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Type 2 Diabetes (T2D) * Age: Between 21 and 70 y.o. * BMI: \<35 * A1c 8.0-12.0% * Negative drug screen * Not suffering from proliferative retinopathy, significant diabetic renal disease or severe neuropathy (including cardiovascular and gastrointestinal autonomic dysfunction) * Healthy (ND) * Age: Between 21 and 70 y.o. * BMI: \<30 * Negative drug screen * No family history of diabetes among first-degree relatives (mother, father) Exclusion Criteria: * Age: Under 21 or over 70 y.o. * BMI: \>35 for T2D and \>30 for ND * Hypertension * Severe polydipsia and polyuria * Uncontrolled hyperlipidemia * Clinically significant liver dysfunction * Clinically significant kidney dysfunction * Anemia * Clinically significant leukocytosis or leukopenia * Clinically significant thrombocytopenia or thrombocytosis * Coagulopathy * Positive urine drug screen * Urinalysis: Clinically significant abnormalities * Clinically significant electrolyte abnormalities * Smoking \>10 cig/day * Alcohol: Men \>14 drinks/wk or \> 4 drinks/day, Women \>7 drinks/wk or \>3 drinks/day * History of chronic liver disease, active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease * Surgeries that involve removal of endocrine glands except for thyroidectomy * Pregnant women * Subject enrolled in another stu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing

Timeframe: 2 hours and 5 hours post dosing

Trial details

NCT IDNCT03566511

SponsorMeredith Hawkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-01

Results submitted2025-04-17

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials