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New treatment option for Brain Insulin Sensitivity
Official title Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?
ClinicalTrials.gov ID: NCT07109245
What this study is testing
What is Haloperidol?
Haloperidol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for brain insulin sensitivity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aimed at helping researchers understand how a medication called haloperidol can affect insulin action in the brain. Insulin is a hormone in the body that controls sugar levels in part by lowering the amount of glucose produced by the liver.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35. Healthy volunteers may be eligible.
You may be able to join if
- Must be deemed to have the capacity to provide informed consent
- Must sign and date the informed consent form
- Stated willingness to comply with all study procedures;
- Age: 18-35
- Body Mass Index (BMI) 18.5-24.9 kg/m2
You likely can't join if
- History of psychiatric illness, including any substance use (screened using the Mini International Neuropsychiatric Interview (MINI))
- Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c\>6% or use of anti-diabetic drug),
- Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5
- Family history of diabetes in a first degree relative (parent or sibling)
- Use of weight reducing agents
- History of kidney or liver disease
See the full eligibility criteria
- Must be deemed to have the capacity to provide informed consent
- Must sign and date the informed consent form
- Stated willingness to comply with all study procedures;
- Age: 18-35
- Body Mass Index (BMI) 18.5-24.9 kg/m2
- Both sexes
- History of psychiatric illness, including any substance use (screened using the Mini International Neuropsychiatric Interview (MINI))
- Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c\>6% or use of anti-diabetic drug),
- Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5
- Family history of diabetes in a first degree relative (parent or sibling)
- Use of weight reducing agents
- History of kidney or liver disease
- History of cell blood disorders
- Irregular menstrual cycles (e.g., menstruation occurs less than 21 days or more than 35 days apart, or not having menstruated for three months (or 90 days), or conditions such as endometriosis or polycystic ovary...
- Current use of hormonal birth control (e.g., pill, patch, hormonal intrauterine device [IUD], ring). Participants must have had at least 2 regular menstrual cycles following the discontinuation of hormonal birth control...
- Current use of progesterone, estrogen, testosterone, or fertility treatment.
- Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study.
- Major medical or surgical event within the last 6 months
- Contraindications for MRI, including metal implants, pacemakers, cochlear implants, claustrophobia, weight \>250 lbs
- Any contraindications to the investigational products as listed in the product monographs including known hypersensitivity to the drug or the excipients of the product (note: enzymatic lactose intolerance is NOT...
- Any medications that increases risk of hypoglycemia or could contribute to hyperglycemia
- Any medical conditions that constitute as a warning/precaution for haloperidol, lorazepam, benztropine, or insulin.
- Use of any of the prohibited medications listed in the product monograph of haloperidol, lorazepam, benztropine, or insulin (Pheochromocytoma, barbiturates, and narcotics are exclusionary, any use of painkillers and...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.