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 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:
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…
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