View clinical trials related to Type 2 Diabetes.
Filter by:Context and justification: There is growing evidence that the gut microbiota is a key element in the pathophysiology of cardio-metabolic diseases (CMD) such as Type 2 Diabetes (T2D). One hypothesis is that gut-derived metabolites (from diet) have an important role in the host metabolism. Preliminary results show that imidazole propionate (ImP), a degradation product of the essential amino acid histidine, is produced by the gut microbiota of T2D patients, but not healthy subjects. The gut microbiota itself is strongly influenced by diet and ethnicity. However, most dietary intervention studies have focused on the role of fiber intake and the effect of dietary protein on the gut microbiota composition and metabolite production is not well known. Our hypothesis is that, depending on the baseline gut microbiome composition, a diminution in protein intake could decrease the microbial production of metabolites such as ImP and improve the metabolism of the host. We also hypothesize that the effects of such an intervention could depend the ethnic background. Objective: To study the effects of a high protein (HP) vs a low protein (LP) diet on gut microbiota composition and production of pro-diabetic metabolites in type 2 diabetes (T2D) patients from Caucasian and Caribbean ethnicity depending on baseline metagenomics richness. Study design: Randomized controlled three months dietary intervention study Study Population: T2D patients from Caucasian (N=80) and Caribbean (N=40) background who are on a stable dose of metformin and do not use insulin or proton-pump inhibitors. Intervention: Subjects will be randomized to either a high protein (HP) or low protein (LP) diet for three months. Individuals of Caucasian ethnicity, will also be stratified according to either a high or low gut microbiota gene richness. All subjects will receive pre-cooked meals 6 days per week and daily food packages. Subjects are required to keep food diaries three days a week and will also have weekly contact with an Pitié-Salpêtrière dietician. Outcome measures: Primary endpoint is the change in glycemic excursion (area under the curve) after a mixed meal test between baseline and 12 weeks after the beginning of the intervention. Furthermore, we will study oral and fecal microbiota composition changes as well as serum levels of intestinal metabolites, such as ImP, body weight and body composition at baseline and after 12 weeks. Sample Size: It is calculated that a total of 20 patients per arm are needed so 120 patients in total.
The goals of this project are to assess the efficacy of remotely delivered episodic future thinking for reducing delay discounting and improving management of type 2 diabetes, including glycemic control, weight loss, medication adherence, dietary intake, physical activity, and blood pressure. This will be accomplished by randomly assigning participants (N = 64) to episodic future thinking or control thinking groups, while tracking outcome measures before, during, and after the 4-month intervention, as well at a 6-month follow-up visit. Participants in both groups will also receive access to an information-based weight loss intervention.
the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.
This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.
The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.
This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects. The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.
Approximately 39 million people of adults aged 20-79 are living with Diabetes in MENA region in 2017, Egypt is number 8 in the top 10 countries in number of adults with Diabetes (8.2 million), where Egypt represents 21% of the Diabetics in MENA region. Metformin is used as 1st line oral anti-diabetic drug in most cases. Sulfonylureas (SU) are used as frequent first add-on after failure of metformin monotherapy. Sodium Glucose Co-transporter 2 (SGLT2) inhibitors are a newer class of therapy which has a lower incidence of hypoglycemia and in addition helps in weight and BP reduction. In Egypt, SGLT2 inhibitors were introduced in 2016. It is not yet widely used for various reasons including lack of wide clinical experience in Egyptian patients and safety concerns particularly related to infections and some rare Diabetic Ketoacidosis (DKA). Also, usage of SGLT2 inhibitors is limited in the early stage of diabetes as they are usually preferred as 3rd or 4th add-on therapy. The existing dapagliflozin phase-3 clinical trial program on SGLT2 inhibitors didn't include subjects from Egypt. There is no study available which evaluates the effect of dapagliflozin in real world scenario in Egypt. Key opinion leaders in diabetes in Egypt have also identified the need for study on Egyptian subjects to observe the usage pattern and effect of dapagliflozin, a SGLT2 inhibitor, in this specific real world setting. Therefore, there is a need for data on real world setting across Egypt. With this aim in mind, the present study has been planned.
The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.
This study seeks to determine if a specialized multidisciplinary diabetes team (SMDT) approach that incorporates the use of the chronic care model can be an effective method for improving glycemic control in Hispanic adults with uncontrolled type 2 diabetes residing in the Rio Grande Valley. The study will expand the current model of care used and focus on the multidimensional aspects that consist of physical, nutritional, educational and psychological needs of this underserved Hispanic population residing in the Rio Grande Valley.
This is a longitudinal study that will collect demographic, anthropometric and dietary data to determine the relationships between meat and egg intake and the incidence of Type 2 Diabetes.