Regulation of Endogenous Glucose Production by Central KATP Channels (NCT03540758) | Clinical Trial Compass
RecruitingPhase 2
Regulation of Endogenous Glucose Production by Central KATP Channels
United States100 participantsStarted 2018-08-01
Plain-language summary
Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals.
The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.
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:
For healthy (non-diabetic) participants:
* Age: 21-70 years old
* Body Mass Index (BMI) under 40 kg/m\^2
* Negative drug screen (see below)
* Normal Hemoglobin A1c (HbA1c) and fasting glucose
* In general good health (see below for exclusions)
* Not participating in any other research study besides those done by the study team
For T2D participants:
* Age: 21-70 years old
* BMI under 40 kg/m\^2
* Stable and moderate-to-poor glycemic control (HbA1c: 8.0-12.0%)
* Negative drug screen (see below)
* Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease (urinary microalbumin \<100 μg/dl) or severe peripheral neuropathy (including cardiovascular and gastrointestinal autonomic neuropathy) per medical history
* Diabetic subjects will be otherwise in good health (see below for exclusions), taking no medications that might affect study eligibility based on review by study doctor, and not participating in any other research study besides those done by the study team
Exclusion Criteria:
* Age: Under 21 or over 70 years old
* BMI: \>40 kg/m\^2 for Type 2 Diabetes (T2D) and Non-Diabetic (ND) subjects
* Blood pressure \>150/90 or \<90/60 on more than one occasion
* Severe polydipsia and polyuria (in subjects with T2D). Since polydipsia and polyuria are common symptoms of T2D, the distinction "severe" denotes that the subject indicates a worsening in the symptoms and/or an experience of discomfort related to the sympt…
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
1
Change in Endogenous glucose production (EGP) rate
Timeframe: 7 hour infusions, 4 days in total, separated at least 1 month apart, up to 1 year duration