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!
New photocatalyst speeds up the conversion of carbon dioxide into chemical resources
29.05.2017 | DGIST (Daegu Gyeongbuk Institute of Science and Technology)
Copper hydroxide nanoparticles provide protection against toxic oxygen radicals in cigarette smoke
29.05.2017 | Johannes Gutenberg-Universität Mainz
The world's highest gain high power laser amplifier - by many orders of magnitude - has been developed in research led at the University of Strathclyde.
The researchers demonstrated the feasibility of using plasma to amplify short laser pulses of picojoule-level energy up to 100 millijoules, which is a 'gain'...
Staphylococcus aureus is a feared pathogen (MRSA, multi-resistant S. aureus) due to frequent resistances against many antibiotics, especially in hospital infections. Researchers at the Paul-Ehrlich-Institut have identified immunological processes that prevent a successful immune response directed against the pathogenic agent. The delivery of bacterial proteins with RNA adjuvant or messenger RNA (mRNA) into immune cells allows the re-direction of the immune response towards an active defense against S. aureus. This could be of significant importance for the development of an effective vaccine. PLOS Pathogens has published these research results online on 25 May 2017.
Staphylococcus aureus (S. aureus) is a bacterium that colonizes by far more than half of the skin and the mucosa of adults, usually without causing infections....
Physicists from the University of Würzburg are capable of generating identical looking single light particles at the push of a button. Two new studies now demonstrate the potential this method holds.
The quantum computer has fuelled the imagination of scientists for decades: It is based on fundamentally different phenomena than a conventional computer....
An international team of physicists has monitored the scattering behaviour of electrons in a non-conducting material in real-time. Their insights could be beneficial for radiotherapy.
We can refer to electrons in non-conducting materials as ‘sluggish’. Typically, they remain fixed in a location, deep inside an atomic composite. It is hence...
Two-dimensional magnetic structures are regarded as a promising material for new types of data storage, since the magnetic properties of individual molecular building blocks can be investigated and modified. For the first time, researchers have now produced a wafer-thin ferrimagnet, in which molecules with different magnetic centers arrange themselves on a gold surface to form a checkerboard pattern. Scientists at the Swiss Nanoscience Institute at the University of Basel and the Paul Scherrer Institute published their findings in the journal Nature Communications.
Ferrimagnets are composed of two centers which are magnetized at different strengths and point in opposing directions. Two-dimensional, quasi-flat ferrimagnets...
24.05.2017 | Event News
23.05.2017 | Event News
22.05.2017 | Event News
29.05.2017 | Earth Sciences
29.05.2017 | Life Sciences
29.05.2017 | Physics and Astronomy