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Type 2 Diabetes clinical trials

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NCT ID: NCT06199505 Enrolling by invitation - Type 2 Diabetes Clinical Trials

A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects With T2DM

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.

NCT ID: NCT06067178 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

Health Dialogue Intervention Versus Opportunistic Screening for Type 2 Diabetes and Cardiovascular Disease Prevention

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Chronic diseases such as cardiovascular disease and diabetes type 2 are major causes of death worldwide. Preventive interventions can be delivered through primary care, as this is the first-line healthcare with which a considerable proportion of the population comes into contact every year. The goal of this cluster-randomized trial is to compare the effects of a Health Dialogue Intervention (HDI) to Opportunistic Screening (OS) in primary care among middle-aged adults with low socioeconomic status. The main questions it aims to answer are: - What is the short-term change in cardiovascular risk factors, lifestyle behaviors, and perceived quality-of-life among participants offered HDI, as compared to participants offered OS? - What is the long-term risk of ischemic heart disease, stroke, type 2 diabetes, and death due to cardiovascular disease or type 2 diabetes, among participants offered HDI, as compared to participants offered OS?

NCT ID: NCT06058338 Enrolling by invitation - Type 2 Diabetes Clinical Trials

Pathway for Produce Prescriptions in Diabetes Management

PPT2D
Start date: May 31, 2023
Phase: N/A
Study type: Interventional

Fruit and vegetable (FV) intake decrease the risk of type 2 diabetes (T2D) and is important for T2D management but is difficult to achieve in adequate amounts for those with a low- income. Produce Prescription (PPR) projects are an intervention aligned with the social determinants of health that help individuals with a low-income purchase FV by providing an incentive. The impacts of PPR projects on populations with T2D and a low-income is less understood. The Multi-level evaluation of Produce Prescription Projects on type 2 diabetes- related outcomes: A pathway to policy change by addressing social determinants of health study will determine the impact of PPR projects on hemo-globin A1c (HbA1c; primary outcome), fruit and vegetable intake (FVI), food security, and related behaviors among a diverse sample of PPR participants diagnosed with T2D and low-income (Aim 1), and will conduct a cost and cost-effective analysis of PPR projects (Aim 2), and a mixed methods process evaluation to understand feasibility and best practices for PPR projects for people with/at risk for T2D (Aim 3). We hypothesize that PPR participants will see greater declines in HbA1c and improvements in other health and food-related behaviors, compared to the Standard of Care. We will recruit five GusNIP PPR projects, whose healthcare partners serve patients with T2D, and who have participating and matched non-participating control populations. We will collect data at baseline and post-intervention using validated, survey modules, clinical measures, and cost data. Five types of data will be used for this project: 1.Health and healthcare utilization data from the EHR or point-of-care, 2.Participant survey data, 3.Qualitative data, 4.Program cost data (NOT human subjects), and 5.Process data (NOT human subjects). Information extracted from medical records includes HbA1c, weight, and blood pressure and will be collected at 2 time points (months 0,6), following their standard of care protocols. Staff will also extract healthcare utilization data (e.g., #primary care and #ER visits) from the EHR at each of site. Primary analyses will use an intention to treat strategy. Analysis will include a linear mixed-effect model to the HbA1c with an interaction between group and time to examine whether there is a difference in HbA1c trajectories between intervention and control groups. Similar models will be used to determine impact on each of the secondary outcomes (e.g., healthcare utilization, BMI).

NCT ID: NCT06002048 Enrolling by invitation - Type 2 Diabetes Clinical Trials

AI Ready and Equitable Atlas for Diabetes Insights

AI-READI
Start date: July 19, 2023
Phase:
Study type: Observational

The study will collect a cross-sectional dataset of 4000 people across the US from diverse racial/ethnic groups who are either 1) healthy, or 2) belong in one of the three stages of diabetes severity (pre-diabetes/diet controlled, oral medication and/or non-insulin-injectable medication controlled, or insulin dependent), forming a total of four groups of patients. Clinical data (social determinants of health surveys, continuous glucose monitoring data, biomarkers, genetic data, retinal imaging, cognitive testing, etc.) will be collected. The purpose of this project is data generation to allow future creation of artificial intelligence/machine learning (AI/ML) algorithms aimed at defining disease trajectories and underlying genetic links in different racial/ethnic cohorts. A smaller subgroup of participants will be invited to come for a follow-up visit in year 4 of the project (longitudinal arm of the study). Data will be placed in an open-source repository and samples will be sent to the study sample repository and used for future research.

NCT ID: NCT05754775 Enrolling by invitation - Type 2 Diabetes Clinical Trials

Remission of Type 2 Diabetes Via Calorie Restriction

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The primary purpose was to evaluate the efficacy of Korean low-calorie diet for obese adult patients with type 2 diabetes with a body mass index of 25 kg/m2 or higher.

NCT ID: NCT05530356 Enrolling by invitation - Obesity Clinical Trials

Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study

HEIRitage
Start date: September 30, 2022
Phase:
Study type: Observational

The current protocol plans to enroll participants with youth-onset Type 2 Diabetes (T2D) as well as obese and lean controls from the Renal-HEIR - Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study (n=100) [COMIRB #16-1752] in a prospective investigation that seeks to 1) define the changes in kidney function by gold standard techniques and energetics by functional Magnetic Resonance Imaging (MRI) in adolescents with and without T2D as they transition to young adulthood; 2) quantify kidney oxidative metabolism by 11C-acetate Positron Emission Tomography (PET) in a subset of participants who are ≥18 years of age with youth-onset T2D and/or obesity; 3) determine peripheral arterial stiffness by SphygmoCor. Mechanistic insight will be provided by transcriptomic analyses of repeat biopsies 3-years after their initial biopsy for eligible participants with youth-onset T2D, as well as molecular analysis of tissue obtained from J-wire endovascular biopsies. This study will also leverage this well-characterized cohort of youths to define youth-onset T2D-related changes in brain morphology and function by structural MRI and resting-state functional MRI and through the assessment of cognitive function (fluid and crystallized intelligence) using the NIH Toolbox Cognitive Battery (NIHTB-CB), as an exploratory objective. All enrollees in Renal-HEIR have consented to be contacted for future research opportunities.

NCT ID: NCT05367622 Enrolling by invitation - Type 2 Diabetes Clinical Trials

Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with Type 2 diabetes. A prospective, randomized, double-blind experimental study is designed with 60 diabetic patients randomly assigned to the experimental group receiving continuous blood glucose monitoring and self-regulation mode of health education and the control group receiving self-monitoring of blood glucose and routine health education. Data will be collected three times, including blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.

NCT ID: NCT05351190 Enrolling by invitation - Type 2 Diabetes Clinical Trials

Community Glucose Monitoring Project

CMGProject
Start date: May 15, 2022
Phase: N/A
Study type: Interventional

The investigators believe that addition of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome in patients with Type 2 diabetes compared to self-monitored blood glucose (SMBG), for patients who are not at target A1C regardless of treatment modality. The investigators aims to assess glycemic and quality of life (QoL) benefits of adding and using RT-CGM patients with Type 2 Diabetes Mellitus (T2DM), not at their A1C goal and relying on SMBG for diabetes-management decisions.

NCT ID: NCT05200390 Enrolling by invitation - Type 2 Diabetes Clinical Trials

Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes

Start date: January 24, 2022
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM). The objectives of the study are to 1) Determine if there is difference in diabetes control in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2, 2) Compare participant satisfaction with glucose monitoring and diabetes distress in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2 and 3) Compare the frequency of hypoglycemia in adult participants with type 2 diabetes before and after management with FreeStyle Libre 2.

NCT ID: NCT05166447 Enrolling by invitation - Obesity Clinical Trials

Twenty-year Follow-up of the Inter99 Cohort

Start date: September 13, 2021
Phase:
Study type: Observational

Being born small increases your risk of developing Type 2 diabetes (T2D) with age. Furthermore, data even suggest that some of the diseases ("complications") in the eyes, kidneys, nerves, liver, blood vessels and heart often seen in T2D patients may not only be due to high blood sugar levels, but rather they to some extent are due to reduced growth in your mother´s womb. The Inter99 cohort included 6784 Danish citizens aged 30 to 60 years when established 20 years ago. Data from the Inter99 cohort showed a strong role of low birth weight (LBW) on T2D risk. The aim is now to reexamine risk of T2D and complications in all the alive 6004 elderly Inter99 participants. Importantly, today there are available techniques to perform detailed examinations for even the earliest signs of complications in both subjects with and without diabetes, and the results of this study will altogether provide important new insights into both the origin and classification of T2D and associated complications. It is hypothesized that being born with lower birth weights increases the adult risk of T2D and heart disease and associated complications in the large and smaller blood vessels.