Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide (NCT03566511) | Clinical Trial Compass
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 range21 Years – 70 Years
SexALL
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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…
What they're measuring
1
Change in Arterial Spin Labeling (ASL) Signal Measured Using 3T MRI From Baseline to 5 Hours Post Dosing