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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT06273020 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke

Start date: November 17, 2022
Phase: Phase 4
Study type: Interventional

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes

NCT ID: NCT06268990 Recruiting - Diabetes Clinical Trials

FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

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

This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects.

NCT ID: NCT06264427 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

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

The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland. The main questions it aims to answer are: - Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes? - Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment? - What is the prevalence of sleep apnea among high-risk individuals in Greenland? - Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea? Participants will: - Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness - Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy - Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation - Blood samples for full genome sequencing

NCT ID: NCT06264258 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Game-based Pediatric Diabetes Education

DVx-T1D
Start date: May 22, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D). The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.

NCT ID: NCT06260722 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

NCT ID: NCT06258473 Recruiting - Hypertension Clinical Trials

Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh: The Dinajpur Study

Start date: January 1, 2024
Phase: Phase 1
Study type: Interventional

In the present implementation study, we aim to document the experience of implementing integrated, decentralized primary care in rural Bangladesh, including components of healthcare provider training, mHealth, decentralization with task shifting, and community-based care, and to generate data on the effectiveness and cost-effectiveness of the multicomponent integrated care as compared to usual care and to mHealth intervention alone. We will also Investigate the factors that explain how the interventions influence hypertension and diabetes management and explore barriers/facilitators to delivering and sustaining intervention. We will conduct mixed-methods research to understand how the intervention influences treatment and prevention in this patient population. Particularly, we will assess lifestyle changes (i.e., smoking, dietary salt intake, physical activity, alcohol consumption), and burden for patients (e.g., waiting time, travel-related cost) at individual and community level. Qualitative data will shed light on facilitators and barriers to hypertension and diabetes prevention and control from the perspectives of patients (and their families), primary care providers, public health officials, and other stakeholders. Additionally, we will undertake a health economic evaluation of the interventions for primary care systems. A comprehensive evaluation of cost and effectiveness will be important for the models tested, providing necessary evidence for policymakers and stakeholders to scale up the interventions. We hypothesize that compared with usual care, the multicomponent decentralized primary care will improve all steps along hypertension and diabetes care continuum. On the other hand, we hypothesize that the mHealth intervention alone (Simple App) may improve BP and glycemic control compared with usual care but will have a limited impact on rates of screening, diagnosis, and treatment. We also hypothesize that the multicomponent integrated care will lead to a higher treatment success rate relative to mHealth intervention alone.

NCT ID: NCT06250192 Recruiting - Diabetes Mellitus Clinical Trials

Educational TOolS for Pregnant Women With Diabetes Mellitus.

ETOS-DM
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

A randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of diabetes technology in addition to usual individual face-to-face education, will improve glycemic control and pregnancy outcome ij women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.

NCT ID: NCT06248190 Recruiting - Stroke Clinical Trials

ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

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

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are: 1. To test and estimate the effect of the intervention in people with MLTCs attending PHCs on: i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care 2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance. 3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention. The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

NCT ID: NCT06245980 Recruiting - Diabetes Mellitus Clinical Trials

Role of SGLT2I in Patients With Myocardial Infarction

Start date: January 1, 2018
Phase:
Study type: Observational

Role of sglt2I in diabetic patients with myocardial infarction

NCT ID: NCT06238778 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec

OPTI-2
Start date: January 23, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. One group of patients will get the liver targeting insulin, and the other group will use insulin they normally use for treating Type 1 diabetes. The participant will be part of the study for up to 32 weeks.