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NCT01991197
The primary purpose of this study is to determine if sitagliptin (Januvia®) improves psoriasis severity after 16 weeks of treatment in 20 participants with both psoriasis and type 2 diabetes mellitus. We will compare the change in psoriasis severity in 20 participants treated with Januvia® to 20 participants treated with 16 weeks of a comparator drug (gliclazide, Diamicron®). Participants will be recruited from two centres and after a 4 week washout period will be followed prospectively for 36 weeks. Participants will be stratified by centre, psoriasis severity and obesity status after which they will be randomly allocated to Arm A or Arm B. Participants will be treated with either Januvia® and Diamicron® matched placebo capsules (Arm A), or Diamicron® and Januvia® matched placebo tablets (Arm B) for 16 weeks and then proceed to an open-label phase where all participants will receive Januvia® for a further 16 weeks. Both the research participants and the investigators will be unaware of the trial arm to which the research participant has been allocated (double-blind study). Research participants will be prohibited from making any changes to the dose of medications used to treat psoriasis. If a participant's plasma glycated haemoglobin level (HbA1c) (reflects a participant's glucose control over the previous 3 months) is above 64mmol/mol eight weeks after commencing one of the study investigational medicinal products (IMPs) insulin therapy will be used to improve glycaemic control. Participants will be assessed at 9 study visits over 40 weeks. Participants will complete questionnaires, have a medical history recorded and physical examination, blood sampling and skin biopsies taken (in a small number of willing participants at 3 visits). The following endpoints will be analysed: Changes in psoriasis severity at 16 and 32 weeks; changes in validated quality of life scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs, time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic profiles that predicts best response to sitagliptin therapy. We hypothesize that sitagliptin therapy decreases psoriasis severity.
NCT02536248
Inflammatory processes are increasingly being recognized as a critical step in the pathogenesis of both diabetes and heart disease and may constitute a biological link between the two diseases. Inflammatory cytokines increase vascular permeability, change vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important step in the development of atherosclerosis, and adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore, identifying novel therapeutic approaches that would favorably affect inflammation, endothelial function, and glucose is of significant interest. Investigators have recently demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The results also suggest that the beneficial effects of sitagliptin on both inflammation and endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the beneficial effects of sitagliptin on these markers remain to be fully elucidated. The proposed study will address this key issue.
NCT03202277
Type 2 diabetes (T2D) is a national epidemic and current lifestyle programs and medications are not effectively managing the crisis. This project aims to test a novel smartphone-delivered intervention that simultaneously targets multiple health behaviors (i.e., sleep, sedentary behavior, physical activity,dietary intake) within clinical settings at a large Veteran Health Administration regional hospital. If effective, this project has potential for large-scale implementation nationwide through the VA healthcare system and broad applicability for other populations at T2D risk as well as other disorders.
NCT02589756
Obesity represents one of the most important public health challenges for the societies. Although excess energy intake and physical inactivity are major causes of obesity and cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs) with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic reviews and meta-analyses conducted in recent years strongly support a protective association between eating nuts and CVD. The investigators will conduct a randomized controlled clinical trial in adults. The main research questions are: a. Does consumption of fatty fish increase levels of POPs in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? b. Does consumption of fatty fish affect markers of cardiometabolic risks (blood pressure, lipids, glucose and CRP) in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? c. Does consumption of nuts improve markers of cardiometabolic risks in overweight and obese adult Norwegian men and women compared:1. to a control group not consuming nuts or fatty fish and 2. to a group consuming fatty fish. Clinical significance of study: If an increase in POP levels is seen, and correlates with cardiometabolic risks, this may indicate the need to look further at a causal relation between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish, this could be important dietary information for populations at high risk of CVD.
NCT03384758
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
NCT00419562
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA). The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
NCT04379427
Measurement algorithm control and optimization with subsequent performance evaluation of Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment.
NCT03013985
The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.
NCT04375943
The study has been carried out to determine diagnostic and therapeutic pathways in a group of HF diabetic patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy.
NCT00279305
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta cells have already been destroyed. However, this also means that between 10-20% of these cells remain that continue to produce insulin. Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin. Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack. This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the immune system are well understood through its use in organ transplantation. Research has shown that rituximab might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes. The goal of this study is to find out if rituximab can preserve residual insulin secretion and prevent further beta cell destruction in type 1 diabetes.
NCT00501709
Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
NCT04374864
The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study.
NCT03286751
This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
NCT03166124
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.
NCT02852759
Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per day, to selective regions of the body enriched with brown fat including neck, supraclavicular and interscapular regions) in combination with electroacupuncture (EA). Their insulin sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or serum marker measurements.
NCT03388697
This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the results of this initial trial, investigators plan to perform a larger trial at UTMB. Quantose IR is a fasting blood test for insulin resistance and prediabetes, and is clinically validated in non-pregnant individuals. The Quantose IR Score is based on three novel nonglycemic biomarkers, as well as insulin, and provides a comprehensive measure of insulin resistance. These analytes include: * α-HB (α-hydroxybutyrate): positively correlated with insulin resistance and indicative of early β-cell dysfunction. * L-GPC (linoleoyl-glycerophosphocholine): negatively correlated with insulin resistance and impaired glucose tolerance. * Oleic Acid: positively correlated with increasing lipolysis and insulin resistance. * Insulin: increased insulin is characteristic of insulin resistance and is an independent risk factor for type 2 diabetes and cardiovascular disease. Quantose IGT is designed to estimate the risk of being IGT. It is calculated from a multiple logistic regression model based on the fasting plasma levels of: * Glucose. * α-HB. * β-HB. * 4-methyl-2-oxopentanoic acid. * LGPC. * Oleic acid. * Serine. * Vitamin B5. Participants in the study will be consenting to data collection and two visits for lab draw. The investigators will then evaluate the performance of the Quantose IR and Quantose IGT in the study population.
NCT03072563
The cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral artery pulsatility index (PI) to the umbilical artery PI. In Gestational Diabetes (GDM), the common finding is of accelerated and asymmetric fetal growth. Pregnancies complicated by GDM have an increased risk of certain complications such as preeclampsia, intrauterine demise, CS due to fetal distress. These complications have a well known association with fetal growth restriction leading to the hypothesis that there exists a subset of diabetic fetuses that exhibit a growth restriction phenotype despite not being small for gestational age (\<10%).The objective of this study is to examine whether the CPR can identify GDM fetuses that are not growth restricted but are at increased risk of certain adverse neonatal outcomes. Women with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond will be included. Exclusion criteria are Pre-gestational diabetes, hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW \< 10%(IUGR). Women who consent to the study will have a blinded Doppler assessment of CPR. Clinicians will be blinded to these Doppler measurements (unless they are indicated clinically for another reason (suspected fetal anemia or IUGR development- and the results will be unblinded and reported to the clinicians). Obstetric and neonatal outcomes will be collected prospctively via the local BORN database and the patient chart. Local BORN is needed for the registered outcomes. Newborns will be divided post-hoc into two groups: A) last CPR \<10% B) Last CPR \> 10%. The primary outcome will be a composite outcome consisting of one or more of the following: Caesarean section due to suspected fetal distress, 5 minute Apgar \<7, Cord arterial PH \< 7, HIE, NICU admission \>24 hours.
NCT03227484
Recently, various sodium glucose cotransporter 2 (SGLT2) inhibitors have been approved for the treatment of type 2 diabetes mellitus. Empagliflozin is a preparation of this class of substances. SGLT2 inhibitors also lead to a reduction in body weight in addition to their blood glucose lowering effect. The basis for this is probably the calorie loss by the increased glucose excretion over the urine. However, this weight-reducing effect is lost after a few weeks of treatment and the body weight subsequently stabilizes at a lower level than before. However, patients continue to lose energy via the urine. Hence, the weight stabilization could be due to an increased energy intake as a possible consequence of a changed brain setpoint for the body weight. As the main weight loss is achieved during the first 6-8 weeks of treatment, the investigators assume that the underlying central nervous mechanisms will be present after this time. Furthermore, clinical-experimental observations show that treatment with empagliflozin promotes endogenous glucose production in the liver. This presumably compensatory mechanism also occurs after only a few weeks of treatment. The common mechanism, which could be based both on energy intake and on the endogenous glucose production effect, is still unclear. The investigators suspect that regulatory circuits in the brain contribute to these observed effects. In fact, several studies in animals as well as initial clinical studies in humans show that the brain is involved in eating behavior and peripheral metabolism. In particular, effects of the hormone insulin modulate the dietary intake via the brain, thereby affecting human body weight. Many of the experiments on the insulin sensitivity of the human brain used a specific approach to the selective delivery of insulin into the brain: the application of insulin as a nasal spray. Although this application route has no therapeutic value, this technique allows the administration of insulin to the central nervous system with little effect on the circulating insulin levels. By combining nasal insulin administration with functional MRI, regional insulin sensitivity of the brain can be quantified. The investigators recently found that the insulin action of the brain (stimulated by nasal insulin) regulates both endogenous glucose production and peripheral glucose uptake during hyperinsulinemic euglycemic glucose clamps. The signals from the brain seem to reach the periphery via the autonomic nervous system in order to modulate metabolic processes. A central brain area in this regard is the hypothalamus. This brain region receives afferents over various systems such as the autonomic nervous system and various endocrine systems (including insulin). The investigators recently characterized the hypothalamus as an insulin-sensitive brain area in humans. The hypothalamus is the key area for homeostatic control throughout the body. Since the dietary intake and the endogenous glucose production are modulated by a hypothalamic insulin effect in humans, we suspect that the observed effects of SGLT2 inhibitors on both processes could be due to altered insulin activity in the brain. Since the SGLT2 inhibition by empagliflozin modulates the autonomic nervous system in the kidneys, signals from the kidney may be transmitted to the brain via the autonomic nervous system, thereby changing specific setpoints, including e.g. insulin sensitivity of the brain. In order to test this hypothesis, a precise phenotyping of prediabetic volunteers with regard to regional brain insulin sensitivity as well as the brain effect on metabolism before and after 8 weeks of treatment with empagliflozin compared to placebo is planned.
NCT01679210
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.
NCT03563313
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
