Active clinical trials for "Diabetes Mellitus"

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

The purpose of this study is to evaluate the effectiveness of advanced hybrid-closed loop system, Minimed 780G to glycemic control and safety in children aged 2-6 years with type 1 diabetes. Additionally, the study evaluates the perceived burden of the diabetes treatment to families during the advanced hybrid-closed loop system treatment (diabetes distress). This is a prospective, non-randomized, single-arm study, where primary endpoint is the change in TIR after hybrid-closed loop system initiation. Secondary endpoints are safety (number of severe hypoglycaemias and diabetic ketoacidosis, DKA), HbA1c, time below range (TBR), mean sensor glucose (SG), standard deviation of SG, and coefficient of variation (CV). The inclusion criteria are 1) TDD (total insulin daily dose) ≥ 8 units, 2) HbA1c < 10%, 3) capability to use pump and the CGM, and 4) time from diabetes diagnosis more than 6 months. The exclusion criteria are hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial.

This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and <18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: Up to 5-week screening/run-in period 26 week randomized treatment period 26-week treatment extension 4-week follow-up period

The project aims to achieve significantly improved clinical care for type 2 diabetes. The current standard treatment metformin has low adherence due to its main side effect gut dysbiosis, which also results in more complications and high overall costs. Prebiotics have been suggested as a medical food and might be helpful as adjuvant management in type 2 diabetes and other metabolic diseases. Carbiotix AB has developed, a corn fiber extract containing arabinoxylan-oligosaccharides (AXOS), which have great potential for improving gut health. In this project, it will be investigated whether the intake of a hybrid product containing AXOS together with metformin can significantly improve glucose metabolism and gut health in patients with type 2 diabetes.

The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. .

Type 2 Diabetes Mellitus (T2DM) is a group of metabolic disorders characterized by hyperglycemia in the absence of treatment, positioned in the first places of prevalence and mortality in the Mexican population. Adherence to treatment is a central element to prevent complications of the disease, where the active participation of the patient in his or her treatment is fundamental. Despite institutional healthcare efforts to promote this element, there is no clarity in the Clinical Practice Guidelines aimed at the attention of people with T2DM on how to achieve it. The aim of this project will be to evaluate the effect of an intervention based on Contingency Behavior Analysis on treatment adherence, quality of life and glycemic level in people with newly diagnosed T2DM. Pre-experimental design with pretest and posttest measurements. The Dependent Variable will be an intervention based on Contingency Behavior Analysis. The Independent Variables will be adherence to treatment, quality of life and glycemic level. The power calculation suggests an n = 38, using sequential non-probability sampling. People older than 18 years with less than 5 years of T2DM diagnosis will be included. Pretest and posttest differences, effect size and correlations between measurement variables will be analyzed. It is expected that the intervention based on Contingency Behavior Analysis will encourage the active participation of people with T2DM, improving their adherence to treatment, glycemic level and quality of life. Considering that the Clinical Practice Guidelines emphasize the importance of therapeutic adherence through the active participation of the patient and his/her environment, it is expected that this project will provide the tools for behavioral change that so far are not included in public health in Mexico.

Gestational diabetes mellitus (GDM) is the hyperglycemia with first onset or recognition during pregnancy, of which prevalence has been sharply increased worldwide in the past decades. Nuts offer numerous health benefits, mainly in relation to cardiovascular diseases as well as other chronic conditions. Pistachios have a balanced nutrition profile with lower fat [polyunsaturated fatty acids (PUFAs) and monounsaturated fatty acids (MUFAs)], higher protein, fiber (both soluble and insoluble), potassium, phytosterols, γ-tocopherol, vitamin K, xanthophyll carotenoids and rich antioxidant phytochemical constituents (stigmasterol, campesterol, resveratrol, catechins, lutein and zeaxanthin). Recent researches have found that nutritional intervention of the Mediterranean diet with an enhanced consumption of extra virgin olive oil and pistachios lowered incidence of GDM and other adverse outcomes (urinary tract infections, emergency C-sections, perineal trauma, large-for-gestational-age and small-for gestational age newborns) for pregnant women. Another clinical trial compared the acute metabolic effect of pistachios and isocaloric whole-wheat bread in women with GDM, finding significantly improved glucose and insulin responses, higher GLP-1 and lower gastric inhibitory polypeptide (GIP) levels in those consuming pistachios. However, more compelling evidences are still in need to throw light on the long-term effects of pistachio consumption on maternal and offspring's outcomes for GDM patients. Besides, effects of pistachios on the thorough metabolic profile of GDM patients also need to be elucidated. This study aims to further demonstrate the long-term health effects of pistachio consumption on glycemic control, lipid profile, gut hormone responses, inflammatory condition and pregnancy outcomes for women with GDM. The clinical study is a randomized, controlled, two-arm, parallel trial from the diagnosis of gestational diabetes to delivery consisting of six study visits including screening/consent. A total of 80 singleton pregnant women with confirmed diagnosis of GDM will be consecutively recruited, all with the pregestational body mass index (BMI) greater than 24 kg/m2. All subjects will be randomly assigned to intervention group (IG) or stand care control group (CG)), in an allocation ratio of (1:1) in blocks. According to the Chinese nutritional guidelines for GDM women, the energy intake of 1500-1800 kcal/d will be recommended for the included women with pregestational BMI≥24 kg/m2. Standard care and a balanced diet will be recommended to the women in CG incorporating the total nuts intake of less than 2.5 oz per week). While the women in the IG will be offered the otherwise same diet as their counterparts in the CG, except for the extra intake of pistachios of 1.5 oz thrice per week. All participants will be followed up in 2 weeks initially and then once every 4-6 weeks until delivery or termination of pregnancy. The effect of different interventions on the glycemic profile (the continuous glucose monitoring (CGM) plus self-monitoring), lipid profile, gut hormone responses, inflammatory factors and metabolomics profiling (multi-omics data) will be monitored and compared. The pregnant outcome of the two groups will be also followed up and compared eventually. With all data reviewed and analyzed, this study will add evidence to the long-term health effect of pistachios on GDM women.

The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.