Active clinical trials for "Diabetes Mellitus, Type 2"

This study is a randomized, single blinded, cross-over interventional study for evaluating the effect of acupuncture versus sham acupuncture in diabetic type 2 patient in insulin treatment. Primary end-point of the study is the difference of daily units of insulin between treatment and control group; secondary end point are the variation of glycated hemoglobin levels, lipids panel (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides), C reactive protein and adiponectin. Variation of epicardial fat thickness will be also evaluated by echography. Acupuncture and sham treatment will be administered twice a week for 3 months and, after a pause of one month and cross-over between groups for other three months. Acupuncture treatment will include use of somatic points (SP6; ST36; KI3; CV4; CV12; TE5; LI4; LI11; YinTang; ST28; BL23; BL22; BL20; BL13) and auricular points (most tender point on palpation with pressure feelers of 400 g on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points). Sham acupuncture will be applied distal from acupuncture points and areas used for treatment, with shallow insertion and without manipulation of the needle (15 needles in total on thorax, abdomen, back, arms and legs).

This clinical trial will determine if subjects with heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes mellitus (DM2) receiving sodium-glucose cotransporter 2 (SGLTi2) inhibitor therapy (ertugliflozin) alters cardiac metabolism compared to placebo in a single blinded (to subject), randomized, parallel group, active controlled, single center experimental design.

Hyperglycemia affects 30-40% of hospitalized patients. Despite the fact that basal/bolus insulin therapy has been demonstrated to improve glycemic control and clinical outcomes in patients, achieving good glucose control remains a challenge. This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after meals compared to another type of insulin known as Novolog. The study will be performed in patients with type 2 diabetes admitted to the hospital, who are not in the intensive care unit, and who are being seen by the inpatient diabetes consult team. Eligible participants will be treated with Fiasp or Novolog injected multiple times a day before meals and at bedtime, in addition to a once daily injection of insulin glargine as basal insulin. Which type of meal time insulin (Fiasp vs Novolog) the subject gets is decided by chance, like the flip of a coin. Insulin doses will be started and titrated based on a protocol. All the subjects will wear a blinded continuous glucose monitoring (CGM)) sensor placed in their arm which they will wear for 72 hours during the study. The glucose values from the CGM, collected during the time it is worn, will be downloaded and compared to assess the response to the two different types of insulins - Fiasp and Novolog. The goal is to determine if Fiasp works as well as or better than Novolog in controlling blood sugars, particularly after meals, in the subjects of the study.

Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular disease (CVD) and mortality. Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD. Plant-based diets eliminate certain (i.e. vegetarian diet) or eliminate all animal based products (i.e. vegan diet). Clinical trials with plant-based diets have not looked at incidence of CVD as a (primary) outcome, but at intermediate outcomes of cardiovascular risk. A meta-analysis of 8 trials including 369 persons with T2D found an effect of a plant-based diet on glycated hemoglobin (HbA1c) of -0.29% [95% CI: -0.45, -0.12%] relative to mostly (omnivorous) low-fat diets or usual diet. The 95%CI ranged from what the authors had defined as clinically trivial to clinically relevant. For lipids, a network meta-analysis in persons with T2D compared the effect of a plant-based diet to a (omnivorous) low fat diet (274 patients allocated to a plant-based diet vs 2047 patients allocated to low fat diets). Compared to omnivorous low fat diets, the mean effect of plant-based diets on LDL-Cholesterol was -0.33 mmol/L [95%CI:- 0.55, - 0.12]. However, the quality of the evidence for this estimate was graded as low, mainly due to imprecision and within-study-bias. Furthermore, plant-based diets might reduce blood pressure (BP). However, while vegetarian diets reduce BP in patients with and without hypertension, for vegan diets the effect was only significant in patients with a systolic BP>130mmHgz (see section 1.4.3). Additionally, the effect of plant-based diets on inflammation, which might also be causally related to CVD risk in persons with T2D, has not been reported in trials with persons with T2D. Furthermore, most clinical trials of plant-based diets in persons with T2D have used resource intensive interventions, like weekly group meetings and cooking sessions. The effect of an online plant-based dietary intervention, which is more scalable, has not been reported in clinical trials. Lastly, factors influencing adherence in these trials have not been reported. In summary, plant-based diets likely lower CVD risk by lowering HbA1c, LDL cholesterol and potentially blood pressure in persons with T2D. However, estimated effect sizes are imprecise and the effect on inflammation is still unknown. Furthermore, trials to date have used resource intensive interventions. Thus, the present trial aims to study the effect of a primarily online plant-based dietary program on (cardio)vascular risk factors in persons with T2D. Additionally, adherence and factors influencing adherence will be investigated. Participants will be randomized to the intervention or control group. The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions. Researchers will compare the intervention group to the control group, that continues with usual diet, to see if the cardiovascular risk profile of the intervention group improves.

The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.

To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.

The aim of the study is to assess the safety and efficacy of Curcumin supplementation in combination to the conventional therapy in improving the clinical outcomes, oxidative stress and inflammation in diabetic patients with risk of ASCVD.

The goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). The main questions it aims to answer are: To clarify the efficacy of anti-VEGF drugs combined with SML therapy on retinal function and anatomical recovery in DME patients. To explore the changes in visual acuity and optical coherence tomography angiography (OCTA) parameters before and after the treatment of DME with anti-VEGF drugs combined with SML, and further explore the changes in morphological characteristics of retinal microvessels and the potential treatment mechanism. Participants will randomly be given Intravitreous injection of anti-VEGF drugs or anti-VEGF drugs combined with SML therapy. All participants will be followed up for 6 months after treatment.

Use of real-time continuous glucose monitoring (RT-CGM) systems in inpatient settings especially during the COVID-19 pandemic, may allow hospital staff to remotely monitor glucose while reducing viral exposure and preserving use of PPE. RT-CGM may be of benefit to inpatients with unstable glycaemia and at risk of severe hypoglycaemia, as it can automatically alert the treating clinical team of hypo and hyperglycaemia. This is of clinical relevance as up to 45% of inpatients with diabetes were found to have asymptomatic hypoglycaemia events in hospital, especially overnight. It may therefore provide a safer method of monitoring glycaemia in hospital compared to conventional bedside capillary glucose testing, by minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes. The aim of this pilot study is to to demonstrate that use of Dexcom G6 RT-CGM may provide a safer and effective method of monitoring glycemia in hospital. Data from this pilot study will be used to design and implement a larger multi-centre pivotal trial.

The purpose of this study is to explain the effect of food order/nutrient sequencing on glycemic excursions over a 2 week period, utilizing a device known as a continuous glucose monitor (CGM), for people who have been diagnosed with Type 2 Diabetes Mellitus and treated with metformin. This research study is being done because recent studies demonstrate that besides carbohydrate amount and type, the sequential order of macronutrient consumption during a meal has a significant impact on post-meal glucose levels.