Regulation of Endogenous Glucose Production by Central KATP Channels

Status Recruiting

Clinical Trial Summary

Type 2 diabetes 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.

Clinical Trial Description

In this study, the investigators will study healthy participants and participants with type 2 diabetes through a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (a measure of the body's production of sugar) will be measured in patients given diazoxide (a medication that activates potassium channels in the brain that may affect glucose production in the liver through brain-liver signaling), compared with when a placebo is given. This study will also investigate whether lowering free fatty acid levels which may help improve the the body's ability to regulate glucose levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03540758
Study type	Interventional
Source	Albert Einstein College of Medicine
Contact	Meredith Hawkins, M.D., M.S.
Phone	718-430-2903
Email	meredith.hawkins@einsteinmed.edu
Status	Recruiting
Phase	Phase 2
Start date	August 1, 2018
Completion date	April 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02771093` - An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus	Phase 4
Completed	`NCT02545842` - Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)	Phase 4
Recruiting	`NCT03436212` - Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.	N/A
Completed	`NCT03244800` - A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.	Phase 2
Completed	`NCT03960424` - Diabetes Management Program for Hispanic/Latino	N/A
Withdrawn	`NCT02769091` - A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes	Phase 2
Recruiting	`NCT06065540` - A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor	Phase 3
Recruiting	`NCT05008276` - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Completed	`NCT04091373` - A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide	Phase 1
Completed	`NCT03296800` - Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects	Phase 1
Recruiting	`NCT06212778` - Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
Completed	`NCT05979519` - Fresh Carts for Mom's to Improve Food Security and Glucose Management	N/A
Recruiting	`NCT05579314` - XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)	Phase 1
Completed	`NCT03859934` - Metabolic Effects of Melatonin Treatment	Phase 1
Terminated	`NCT03684642` - Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin	Phase 3
Completed	`NCT03248401` - Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes	Phase 4
Completed	`NCT03644134` - A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns	N/A
Completed	`NCT05295160` - Fasting-Associated Immune-metabolic Remission of Diabetes	N/A
Completed	`NCT02836873` - Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment	Phase 3
Completed	`NCT02226003` - Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)	Phase 3