Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance (NCT03383822) | Clinical Trial Compass
CompletedPhase 1/2
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
Canada7 participantsStarted 2015-09-08
Plain-language summary
It is well known that the hormone insulin lowers blood glucose in part by acting directly on the liver and reducing hepatic glucose production. Animal studies have shown that the hormone insulin can act on the brain to indirectly lower glucose production by the liver. It has previously been shown that a nasal spray can deliver insulin directly to the brain without affecting circulating insulin concentration in humans. Intranasal spray of insulin suppressed hepatic glucose production in lean subjects. It is unknown whether this effects is blunted in subjects with insulin resistance.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Men and women, aged 18 to 60 years
✓. Body mass index \>30 kg/m2
✓. Hemoglobin in the normal range.
✓. Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
✓. Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.
Exclusion criteria
✕. Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
✕. Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
✕. Any current or previous history of endocrine disease, dyslipidemia or malignancy
✕. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP \> 100 or systolic \> 180 or systolic BP\<100) or proliferative retinopathy