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251 active trials for Type 2 Diabetes

A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes

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.

Start: March 2019

Metabolic Benefits of Drinking Blueberry Tea in Type 2 Diabetes

Plant derived compounds, e.g. flavonoids from dark chocolate, green tea, or blueberries, show great potential as nutraceuticals for the treatment of various diseases such as type 2 diabetes (T2D). Flavonoids have been suggested to improve glucose metabolism, reduce blood lipids, reduce oxidative stress and improve vascular function. For these reasons we recently investigated the effects of daily consumption of locally produced blueberry tea and demonstrated that this could partially restore insulin sensitivity in an animal model. We propose to translate these findings to assess the efficacy of this nutraceutical as a new treatment for improving glucose tolerance in people with T2D.

Start: November 2015

Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes

Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease. To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c). The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabolic risk and kidney function. Lastly, investigators will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome via stool samples and comprehensive metabolomics, satiety hormones, as well as usual dietary intake, and upstream behavioral pathways which may inform dietary intake patterns.

Start: June 2019

Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management

The transition from IV Insulin Infusion (IVII) to Subcutaneous Long-acting insulin injections in Diabetic Ketoacidosis (DKA) management frequently results in rebound hyperglycemia, particularly if there are high insulin requirements that can adversely affect the DKA recovery, increase Length Of Stay (LOS), morbidity, and mortality. Investigators propose a prospective, open-label, intervention, non-randomized, controlled study to test the hypothesis that an insulin glargine dose of 0.4 Units/kg early administered (within four hours) of IVII initiation in DKA management in adult would be effective and safe in shortening the time to anion gap closure comparing to the standard practice.

Start: October 2020

Role of Type 2 Diabetes in Potentiating the Inflammatory Response Post Extracorporeal Circulation After Cardiac Surgery

Adult cardiac surgery ensures the surgical treatment of valvular and coronary pathologies and of heart failure with the placement of ventricular assistance. Extracorporeal circulation (ECC) is one of the major technical advances associated with cardiac surgery to replace cardiac and pulmonary functions during surgery. ECC can nevertheless lead to postoperative complications, the origin of which is linked to the patient's initial contact with the circuit and membranes of the ECC. This contact triggers a series of humoral and cellular reactions that occur in the first few hours after the ECC and the inflammatory syndrome post ECC fades on its own and usually disappears between the 4th and 6th postoperative day. If the inflammatory response post ECC is most often transient, certain conditions will maintain and intensify this response at the origin of postoperative complications, possibly leading to the patient's death. Among these situations, the investigators find the notion of emergency cardiac surgery, a patient's age over 75 years and a preoperative history of decompensated heart failure, renal failure or type 2 diabetes (T2D). The inflammasome family of receptors of the nucleotide oligomerization domain (NOD) type, pyrin domain containing 3, NLRP3, is a multi-protein platform of recent discovery which plays a major role in the signaling pathways of the innate inflammatory response. The role of the activation of the NLRP3 inflammasome in cardiovascular pathologies is now well established and its metabolic priming by hyperglycemia could explain the greater seriousness of these pathologies in T2D patients due to an exacerbated inflammatory response. What is the effect of T2D status on the inflammatory response post ECC, mediated by the NLRP3 inflammasome, in patients after cardiac surgery?

Start: April 2021

The eHealth Diabetes Remission Trial - Pilot Study

Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended. The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.

Start: March 2021

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.

Start: January 2015

Use of Continuous Glucose Monitoring (CGM) in End-Stage Renal Disease (ESRD) Patients With Type 2 Diabetes

The study is conducted to examine the prevalence of hypoglycemia, hyperglycemia and estimate glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis, to assess the accuracy of the CGM in this specific cohort, and to assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia.

Start: November 2020

Effects of Caloric Restriction in Obesity and Type 2 Diabetes

The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation. The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.

Start: May 2013

Comparison of Lobeglitazone With Pioglitazone as Initial Triple Therapy for Diabetes Management

Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.

Start: September 2014

Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study

Glycaemia, insulin secretion and action in morbidly obes subjects with type 2 diabetes after sleeve gastrectomy ond Roux-en-Y gastric bypass: A randomised single centre study.

Start: January 2013

Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled with insulin therapy. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 24 weeks post treatment.

Start: March 2021

AI-Assisted Insulin Titration System on Inpatients Glucose Control

This is a multi-center, open-labeled, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System (iNCDSS) in patients with Type 2 Diabetes Mellitus.

Start: November 2020

Chiglitazar Added to Metformin for Type 2 Diabetes

The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.

Start: April 2021

Exercise Resistance in Type 2 Diabetes

The purpose of this study is to collect data to help researchers identify factors that prevent certain individuals from receiving the beneficial effects of exercise.

Start: August 2013

Impact on Glycemic Variability After Treatment With Dapagliflozin on Type 2 Diabetes Patients

Glycemic variability is refered as swings in glucemic concentration throughout the day, including preprandial and postprandial glucose, and it has been proposed that could be determinant in the development in microvascular complications of type 2 diabetes (Brownlee and Hirsch 2006) SGLT2 inhibitors (SGLT2i) are a novel group of medications for treating type 2 diabetes patients but their effect on glucose variability, and oxidative stress has not been determined as a primary endpoint in clinical trials of type 2 diabetes mellitus patients. The aim of this study is to compare the effect of SGLT2 inhibition on glucose variability, oxidative stress and inflammatory disease biomarkers (VCAM-1) on new onset type 2 DM patients.

Start: August 2019

Determining the Minimal Amount of Exercise to Improve Glycaemic Control

In 2015, there were 415 million adults worldwide with type II diabetes and by 2040, typeII diabetes will affect one in ten adults worldwide. Type II diabetes reduces quality of life and total lifespan, and two of the best countermeasures to type II diabetes are not drugs, but diet and exercise. Several studies have investigated the effects of exercise modality (aerobic, resistance, or concurrent) on glycaemic control and the mechanisms of these benefits. However, the minimal 'dose' of exercise required to increase insulin sensitivity and improve glycaemic control has never been established. Secondly, there is a progressive loss of muscle structure and function with age, which is known as sarcopenia. This study will also investigate whether the minimal amount of exercise is influenced by biological age and muscle mass by comparing physiological and biochemical responses in BMI-matched young and old volunteers. This study will therefore provide pilot data on the effect of age on exercise-mediated glycaemic control.

Start: October 2019

Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients

The study was designed to investigate the correlation between perioperative adverse cardiovascular events and the degeneration of sensory nerves in patient diagnosed with type 2 diabetes mellitus, undergoing elective non-cardiac surgery.

Start: October 2020

Effect of Pioglitazone on T2DM Patients With COVID-19

Approximately 10-15% of patients infected with COVID-19 develop severe illness characterized by respiratory distress, increased risk of clotting disease, myocardial damage, stroke and mortality. Subjects with Type 2 diabetes (T2DM) are at increased risk for severe COVID-19 disease. Exuberant inflammatory and immune responses were suggested as the etiology responsible for the development of severe COVID-19 disease. The increased chronic inflammatory state characteristic of T2DM could contribute to the increased risk of severe COVID-19 disease in T2DM patients. Therefore, its possible that anti-inflammatory therapy will reduce the risk of severe COVID-19 disease. Consistent with this assumption, a recent study has reported that steroid therapy improves the outcome in patients with severe COVID-19 disease. The medication pioglitazone is a strong insulin sensitizer that reduces plasma glucose concentrations in T2DM patients. In addition to improving insulin sensitivity, several studies have demonstrated that pioglitazone reduces chronic inflammation in T2DM patients, which is manifested in a decrease in TNF-alpha, interleukin, hs CRP, leptin and other inflammatory markers in T2DM treated with pioglitazone. Further, pioglitazone enhances the plasma level of anti-inflammatory agents. For example, the plasma level of 15-epi-lipoxin A, a lipid mediator with strong anti-inflammatory and inflammation-resolving effects that has been reported to neutralize RNA coated viruses, is significantly elevated by pioglitazone treatment in T2DM patients. Therefore, we hypothesize that administering pioglitazone to T2DM patients who have moderate-to-severe COVID-19 will improve the clinical outcome of their COVID-19 disease.

Start: January 2021

The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time

This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.

Start: August 2019