This is the first type 1 diabetes treatment trial involving leptin, which is naturally produced by fat cells and involved in body-weight regulation. For this study, UT Southwestern researchers will be using metreleptin, a slightly modified form of the hormone that has been well-tolerated in other clinical trials.
"Leptin has been very effective in improving diabetes in patients with lipodystrophies who have extreme lack of body fat, and recently leptin therapy has helped improve blood sugar control in animal models of type 1 diabetes," said Dr. Abhimanyu Garg, professor of internal medicine and principal investigator of the trial. "Although we have no assurances that this will work in humans, we hope that the addition of leptin will be beneficial to patients with type 1 diabetes."
The phase 1 study also is designed to evaluate the safety and tolerability of adding leptin to a diabetes treatment regimen.
In type 1 diabetes, formerly known as juvenile-onset diabetes, the pancreatic beta cells that produce insulin are destroyed by an autoimmune process. Type 1 diabetics must regiment their diets and take insulin multiple times a day to control blood-sugar levels and prevent diabetic coma. The autoimmune disease, for which there is no cure, affects about 1 million people in the U.S.
Insulin treatment has been the gold standard for type 1 diabetes since its discovery in 1922. The laboratory of Dr. Roger Unger, professor of internal medicine at UT Southwestern, previously found that insulin's benefit resulted from its suppression of glucagon, a hormone produced by the pancreas that raises blood-sugar levels in healthy individuals.
More recently, Dr. Unger's lab, using mouse models of type 1 diabetes, found that administering leptin instead of insulin resulted in better management of blood-sugar variability and lipogenesis, the conversion of simple sugars into fatty acids.
For the clinical study, 12 to 15 participants will add leptin twice a day to their standard insulin therapy over a five-month period. The trial will last a total of seven months and will include 11 visits – an initial screening, four inpatient visits and six outpatient evaluations – to UT Southwestern. The first inpatient visit will last a minimum of four days; the others will take two days each.
To be eligible for the initial screening, prospective trial participants must be between 18 and 50 years of age, have a body mass index (BMI) less than 25, and have been diagnosed with type 1 diabetes. BMI is a weight-to-height ratio commonly used in doctors' offices to gauge obesity. A normal BMI is between 18.5 and 25.
Dr. Gregory Clark, assistant professor of internal medicine and a trial investigator, said one incentive to take part in the trial is that participants might lose weight.
"Leptin is known to decrease appetite, so it's likely that participants won't be as hungry," he said. "We hope that the addition of leptin also reduces the blood levels of cholesterol, which increase the risk of coronary heart disease, one of the long-term complications of diabetes."
Dr. Unger emphasized that the goal is not to find a replacement for insulin, but to obtain stable glucose levels, something that has eluded monotherapy with insulin. The theory is that adding leptin might allow a substantial reduction in insulin dose and lower the risk of low blood glucose levels.
"If it works in humans as well as it does in rodents, it will be a major step forward," said Dr. Unger. "In rodents, it eliminated the wide swings in glucose that occur with insulin alone and lowered indices of cholesterol formation. The hope is that it will improve both short- and long-term quality of life for patients with type 1 diabetes."
Other UT Southwestern researchers involved in the trial include Dr. Pablo Mora, associate professor of internal medicine, and Dr. Zahid Ahmad, postdoctoral trainee in internal medicine.
For more information about the clinical trial, call 214-648-3621 or 214-648-9296.
Visit www.utsouthwestern.org/endocrinology to learn more about UT Southwestern's clinical services in endocrinology, including diabetes.
This news release is available on our World Wide Web home page at http://www.utsouthwestern.edu/home/news/index.html
To automatically receive news releases from UT Southwestern via e-mail, subscribe at www.utsouthwestern.edu/receivenews
Kristen Holland Shear | EurekAlert!
Toward a 'smart' patch that automatically delivers insulin when needed
18.01.2017 | American Chemical Society
127 at one blow...
18.01.2017 | Stiftung Zoologisches Forschungsmuseum Alexander Koenig, Leibniz-Institut für Biodiversität der Tiere
Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...
Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.
While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...
Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales
Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...
Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.
As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...
At TU Wien, an alternative for resource intensive formwork for the construction of concrete domes was developed. It is now used in a test dome for the Austrian Federal Railways Infrastructure (ÖBB Infrastruktur).
Concrete shells are efficient structures, but not very resource efficient. The formwork for the construction of concrete domes alone requires a high amount of...
10.01.2017 | Event News
09.01.2017 | Event News
05.01.2017 | Event News
18.01.2017 | Power and Electrical Engineering
18.01.2017 | Materials Sciences
18.01.2017 | Life Sciences