View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting
This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.
This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump. The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered. The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®). Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes. Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance. The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each. During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions. Women: Women cannot take part if they are of childbearing potential.
This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.
This two-year multisite, real-world, before-after prospective six-month pilot study utilizing a single-group cohort design (n=184) which will first occur in London, Ontario (n=92) through the St. Joseph's Primary Care for Diabetes Support (PCDSP) program. To test fidelity, the intervention will be delivered again in Hamilton, Ontario through the Hamilton Health Sciences' Boris Clinic in Diabetes Care and Research Program (n=92). Participants will begin by attending the first class at the PCDSP clinic to complete baseline fitness testing as well as receive/set up their wearable technology (FitBit Inspire 2™ and FreeStyle® Libre sensors). Two weeks of baseline data collection will following (glucose values and step counts). Five bi-weekly, followed by three monthly, one-hour videoconferencing group education classes via Microsoft Teams video platform will be offered. Participants will be given the choice to communicate with the LIBERATE clinical team (exercise specialist, physician, and/or registered) weekly between the group classes using their preferred method of communication i.e., email. Classes will offer FreeStyle® Libre-assisted behavioural coaching (i.e., nutrition and exercise). FreeStyle® Libres will be used during the first three months of the program and optionally in the last three months of the intervention. The FitBit Inspire 2™ monitors will be worn for six months. Participants are provided the option to receive individualized aerobic and resistance training prescriptions. The primary outcome is change in glycated hemoglobin. A main goal of this study is to create a "toolkit" for other Canadian Diabetes Management centres (DMCs) to use in the future.
Despite their potential benefits on the heart with pleiotropic mechanisms, the cardioprotective effects of new glucose-lowering SGLT-2 inhibitors in patients with myocardial infarction - both in the acute and chronic phase - have never been explored. The key point of the project will be the evaluation of the cardioprotective effect and the potential prognostic benefit of SGLT-2 inhibitors in patients with diabetes and acute myocardial infarction.
We hypothesize that the combination of a nutritional education intervention with a HIIT-based physical exercise program improve muscle metabolism through positive modifications of gut microbiota in people with T2DM, leading to better glycaemia/insulinaemia levels, reduction of body fat mass and improving quality of life. The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT. The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, faecal samples, blood samples, blood pressure, appetite assessment, muscle biopsy samples, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.
The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.
The proposed research is an innovative adaptation of the Centers for Disease Control and Prevention's (CDC) Diabetes Prevention Program "Power to Prevent" program, which will be developed and piloted in the low-income peri-urban neighborhoods of Bamako, Mali. This program is well-suited to delivery by the city's community health workers already supporting families in improving maternal and child health outcomes. First, it will use participatory research methods to engage them and community residents in making adaptations to the community health worker's guidelines and tools for recommended activities so that they are linguistically and culturally appropriate, including guidelines for food consumption using locally available foods. These adaptations will use more graphics and photographs, so they are appropriate for low-literacy participants. Second, another key innovation is the explicit orientation to couples, where only one may have a diagnosed cardiovascular disease. This adaptation will provide tools the women can use in negotiating for changes to the family's meals and her daily routine. Third, investigators will conduct a comparative effectiveness study at 6 community health centers with high rates of Cardiovascular Disease (CVD), recruiting adults recently diagnosed with diabetes or hypertension. Based on the random allocation of their community health center, participants will be assigned to one of three groups of 150 each: Couples, with at least one meeting the eligibility criteria; Individuals, men and women, both eligible; Comparison, men and women with CVD. Trained community health workers and diabetic peer educators will use the adapted Diabetes Prevention Program (DPP) materials with the Couples and Individuals groups over a period of 6 months. At the conclusion of this pilot investigators will assess the levels of adoption of recommended cardiovascular risk reduction behaviors and changes in obesity, hypertension, and diabetes control, comparing differences in outcomes between the three groups. It will enable Mali to incorporate diabetes and hypertension risk reduction into their already deployed networks of community health workers. The Malian DPP adaptation will also be suitable for Francophone West Africa, where customs and lifestyles are similar among the millions of families confronting the burdens of cardiovascular disease.
This study aims to compare two common oral hygiene routines on the improvement of glycemic control and oral health parameters in moderate to severe periodontitis patients with uncontrolled type 2 diabetes (T2DM). It is currently unclear if one oral hygiene routine is more effective than the other. The two routines being compared are: Group 1: Scaling and root planing + oral hygiene routine with use of an electric toothbrush (Sonicare Diamond Clean Smart ®) along with its mobile app Group 2: Scaling and root planing + oral hygiene routine with use of manual toothbrush The specific aims of the study are: Aim 1: To assess the impact of Sonicare Diamond Clean Smart ® use on the glycemic control as an adjunct to scaling and root planing and oral hygiene instructions for T2DM patients with moderate to severe periodontitis patients. Aim 2: To assess oral health parameters which include clinical measurements and immune-inflammatory cytokines.