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251 active trials for Type 2 Diabetes

A Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics

Background In management of type 2 diabetes, autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement. Preliminary evidence has previously shown that the autonomy supporting intervention, guided self-determination method might have effect on HbA1c and diabetes distress in people with type 1 diabetes. However, previous trials were all rated as high risk of bias and did not assess potential harm of the the intervention. Thus, in the current trial, the objective is to investigate the benefits and harms of guided self-determination interventions versus an attention control group intervention in adults with type 2 diabetes. Methods/design The trial planned is a randomised, pragmatic, investigator-initiated, dual-centre, parallel group, clinical superiority trial of guided self-determination intervention versus an attention control group for people diagnosed with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from the department of Endocrinology at a University hospital of Copenhagen, the Capital Region of Denmark and from Steno Diabetes Center Odense, University hospital in the Southern Region of Denmark. The experimental stepped-care intervention will consist of 3-5 analogue or digitally provided guided self-determination sessions lasting up to one hour with a guided self-determination facilitator. The attention control group will receive similar number of sessions lasting up to one hour with a communication trained healthcare professional provided face-to-face, digitally, or over telephone.This trial protocol is guided by the SPIRIT and CONSORT guidelines. Participants will be included if they have type 2 diabetes, > 18 years old, and, are not pregnant. Participants will be assessed before randomisation, at 5- and 12-months follow-up. The primary follow-up timepoint will be 12-months follow-up. The primary outcome will be diabetes distress. Secondary outcomes will be quality of life, depressive symptoms, and adverse events not considered serious. Exploratory outcome will be glycated haemoglobin, motivation, and serious adverse events. Data will be collected using REDCap. The analyses will be performed using the statistical programme Stata version 16.

Start: November 2020

Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes

The study team will examine the effect of a ketogenic diet alone and ketogenic diet supplemented with oral ketones on how the body of individuals with type 2 diabetes respond to insulin, regulates insulin secretion, food intake and energetic pathways and influences body fat distribution.

Start: November 2020

A Study of TG103 in Subjects With Type 2 Diabetes

The main purpose of this study is to assess the safety and tolerability of multiple ascending doses of TG103 in subjects with type 2 diabetes.

Start: April 2021

Dynamically Tailored Behavioral Interventions in Diabetes

In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.

Start: January 2020

Cocoa/Carob Polyphenols and Postprandial Changes in Type 2 Diabetes

The aim of this is study is to evaluate the effects of a single intake of a mixture of cacao and carob (rich in high molecular weight polyphenols) in postprandial metabolism in subjects with type 2 diabetes. Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used food extracts, ignoring high molecular weight polyphenols as relevant bioactive compounds. In this study, the potential of this kind of polyphenols for regulating postprandial disturbances in type 2 diabetes subjects, since these alterations increased the cardiovascular risk in these subjects, will be evaluated. The study has been designed in order to differentially evaluate the effect of intact polyphenols and that of microbial-derived phenolic metabolites.

Start: September 2021

A Trial Comparing Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

The purpose of this study is to find out if treatment with Degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes, who are admitted to the hospital and then transition at home, after discharge from the hospital.

Start: January 2018

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

Start: December 2019

Cooking Matters for Diabetes - A 6-Week Program for Practical Application of Diabetes Self-Management Education

Our primary objective is to improve glycemic control (Hemoglobin A1c [HbA1c]) over 3 months in individuals with diabetes by teaching practical application of diabetes education through "Cooking Matters" compared to usual care. Our secondary objective is to improve health related quality of life, adherence to diabetes self-management behaviors (physical activity, diet, glucose monitoring, and medication adherence) over 3-months compared to usual care. We hypothesize that participants in the cooking matters intervention will have significant improvement in glycemic control (HbA1c), HRQOL, and adherence to diabetes self- management compared to usual care. Our study is significant as it examines a novel approach to improving diabetes care and addressing glycemic control in diabetes.

Start: July 2019

Pathophysiological Study of the Increase in Pancreatic Volume in Type 2 Diabetes Treatments.

Incretinomimetics and inhibitors of dipeptidyl peptidase-4 (DPP-4) are new treatments for diabetes. Previous retrospective studies have shown that these treatments induced an increase in pancreatic mass with potentially a risk for pancreatitis and development of precancerous lesions. The aim of our study is to provide a better understanding of the pathophysiological mechanisms of increased volume and / or pancreatic exocrine secretion when exposed to certain treatment of type 2 diabetes.

Start: October 2014

Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

The aim of this study is to investigate the continued usage of standard diabetes medications in the post operative period following bariatric surgery to determine whether this approach may improve long term diabetes control. At present, the standard of treatment in patients with type 2 diabetes is that all medication is stopped in the immediate postoperative period and only re-started if symptoms of diabetes re-emerge. Although a large proportion of patients with diabetes will initially go in to remission, 80% experience relapse within five years. This study is needed to determine whether continuing medications is not only safe but will improve long term outcomes for patients with diabetes.

Start: April 2021

Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada

The purpose of the research study is to describe the burden of disease among three different cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM; and (3) those with T2DM and comorbid CKD.

Start: April 2008

Diabetes Nutrition Education for American Indian and Alaska Native Communities

This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).

Start: February 2020

CHOlesterol Lowering and Residual Risk in Type 2 Diabetes

The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, and genetic information (blueprints of your cells), in participants with type 2 diabetes and elevated cholesterol. This study will also include a control group - subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (PCSK9 inhibitor and statin or ezetimibe) for 1 month with the same risk factors being measured following cholesterol reduction. This study will help understand why individuals with type 2 diabetes are at higher risk for heart disease and stroke before and even after cholesterol reduction.

Start: June 2020

Acute Studies on the Glycemic Index After Intake of Different Sorts of Barley in Subjects With Type 2 Diabetes

In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of different types of barley on the glycemic index (GI) in subjects with type 2 diabetes. The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls off during harvesting, and thereby reduces the need for processing. The investigators want to study how this ancient type of barley affects GI. Furthermore, some of the investigators collaborative partners have made it possible to increase the amount of amylose in regular barley by genetic modification. The investigators want to study the effect on GI of this new type of modified barley.

Start: February 2021

Closed-loop in Adults With T2D Requiring Dialysis

The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over a 20 day period in adults with type 2 diabetes (T2D) requiring maintenance dialysis. This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting. This is an open-label, two-centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 20 days long with a 2-4 week washout period between treatments. A total of up to 40 adults with T2D requiring maintenance dialysis will be recruited through outpatient clinics or the dialysis unit, to allow for 32 completed participants available for assessment. Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system. The primary outcome is time spent with glucose levels in the target range between 5.6 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.

Start: August 2019

The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity

This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity. Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test [OGTT]).

Start: May 2019

Percutaneous CT-guided Cryoablation of the Splanchnic Nerves

The purpose of this study is to evaluate the safety and effectiveness of freezing (cryoablation) of the splanchnic nerve for management of diabetes. The splanchnic nerves carry signals from the brain to help regulate the way organs function. Quieting these signals, by freezing the splanchnic nerves, may help the body regulate blood sugar. The study procedure will take about 30 minutes and the researchers hope that it will help people to control their blood sugars, lose weight, and possibly improve blood pressure.

Start: February 2021

Role of LncRNA H19 in The Regulation of IGF-1R Expression

Hepatocellular carcinoma (HCC) is a common cancer that poses a heavy economic burden on the healthcare system. In Egypt, it is the most common cause of mortality and morbidity-related cancer. Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia. Cancer and type II diabetes (T2DM), the world's two most prevalent diseases, share many overlapping risk factors and predisposing pathological conditions. The exact mechanisms linking those two diseases are yet to be fully understood. In this study, the investigators aim to assess the relationship between Long Non-Coding RNA (lncRNA) H19 and Insulin-Like Growth Factor 1 Receptor (IGF-1R) mRNA gene expressions in the blood samples of HCC & T2DM patients to investigate the probability of the presence of a pathophysiological link between HCC and DM that may become a therapeutic target for both diseases. To the investigator's knowledge, there is currently no human research study investigating both H19 and IGF-1R in both DM and cancer.

Start: January 2020

Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring

The objective of this study is to evaluate a virtual diabetes clinic model, for adults with either T1D or T2D, that supports integration of CGM into diabetes self-management and use of decision support technology.

Start: August 2020

Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study

The overall goal is to determine the real-world feasibility and utility of body fat imaging using rapid MRI to enhance risk perception, induce behavioral change, and improve clinical outcomes in overweight and obese individuals. Here, the investigators will perform a pragmatic clinical effectiveness pilot trial using a 2x2 factorial design to test the hypothesis that provision of a detailed individualized visual report of body fat distribution directly to patients will translate into changes in patient risk perception, behavior, and improved clinical outcomes.

Start: August 2021