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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05203575 Active, not recruiting - Diabetes Clinical Trials

Building a Behavioural Intervention Programme to Improve Self-Management of Diabetes

Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Effective control of diabetes requires patients to change their daily behaviour. The investigators propose an intervention programme for behavioural change with two components, targeting motivation and implementation. The motivation component raises the salience of probable patient-specific detrimental future outcomes by 'fast-forwarding' awareness of these outcomes to the present. The implementation component helps patients to set goals and to act based on weekly tips. A factorial design will be used to establish the necessity and sufficiency of the two components on changing mind and guiding behaviour to improve blood glucose level. Individual-level measures of psychological, physical and medical conditions will be shown to drive the heterogenous responses to the two components. Intervention is expanded into two cycles with crossover design to demonstrate how the individual-level measures drive the wear-off, built-up and persistence of the two components. The results of this two-component programme will serve as a basis for systematic synthesis of component-level effectiveness in behavioural intervention research.

NCT ID: NCT05195502 Active, not recruiting - Diabetes Clinical Trials

Mapping the Human Colon Using Single Cell Sequencing

COLATA
Start date: July 1, 2022
Phase:
Study type: Observational

The overall purpose of this study is to describe the cellular composition of the human colon and its gene expression using scRNAseq and scATACseq methods. This will potentially provide is with a detailed map of the colon aiding our understanding of how diseases of the colon develop as well as the colons influence on systemic diseases such as type II diabetes.

NCT ID: NCT05191160 Active, not recruiting - Obesity Clinical Trials

The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.

NCT ID: NCT05189938 Active, not recruiting - Diabetes Mellitus Clinical Trials

HbA1c Variation Study

Start date: December 20, 2021
Phase:
Study type: Observational

To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.

NCT ID: NCT05161793 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus

TELEMTRRDM
Start date: May 1, 2022
Phase:
Study type: Observational

The purpose of this single center observational study is to determine the effect of continuous remote continuous glucose monitor (CGM) reporting coupled with a telemedicine intervention (Tele-CGM program) on levels of HbA1C in adults with poorly controlled type 1 or type 2 diabetes. The investigators will follow 200 English and Spanish speaking adults (125 type 2 and 75 type 1 patients) who have an HbA1C >8% over 12 months. The primary analysis will follow the intention-to-treat principle; participants will all be offered the intervention. The primary trial outcome of HbA1c/Glucose Management Indicator (GMI) at 6 and 12 months will be compared from baseline using a linear regression model. The primary independent variable will be the HbA1C from baseline to 6 and 12 months. Patients will serve as their own control. Results will be summarized as group-specific mean, standard deviation (SD) HbA1c, along with a mean treatment difference and 95% confidence interval. Model assumptions including normality and homoscedasticity of residuals will be evaluated; normalizing transformations or rank-based non-parametric procedures will be used as needed. The complete evaluation of HbA1c, including baseline, 6-month and 12 month measurements will be analyzed with mixed effects linear regression, specifying a random participant-level intercept and an unstructured covariance matrix, to accommodate the repeatedly measured data. The secondary trial outcomes of time in range (TIR; CGM glucose levels 70-180) and questionnaires will be compared from baseline to 6 and 12 months using linear regression procedures as detailed above.

NCT ID: NCT05145465 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Effect of a Supervised Home-based Tele-rehabilitation Program on Patients With Type 2 Diabetes

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Tele-rehabilitation (TR) which carries health services distant through using electronic communication systems is an important treatment option. Although TR studies in musculoskeletal system, neurologic and cardio-pulmonary diseases are effective TR studies in type 2 DM patients are limited. TR interventions in patients with type 2 diabetes has not yet sufficiently defined and more studies with different exercise protocols will be an important step for the clinical value of this intervention but also for it's application in clinical practice. Objective: The aim of this study is to evaluate the effectiveness of a telerehabilitation program on glucose control, functional capacity, muscle strength and quality of life in patients with type 2 diabetes. Study design: It is a supervised-double blind randomized controlled trial, comparing two groups (a control group and a telerehabilitation group). The duration of the intervention will last 6 weeks. Setting: home-based patients environments , only the first session in University of Thessaly for educational reason Participants: A total of 22 patients with type 2 diabetes, regardless sex, aged 40 years and older will randomly assign to a telerehabilitation group (n = 11) and a control group (n = 11). Measurements /Assessments Study data will be collected at baseline and after the intervention period ( 6 weeks) by two blinded physiotherapists, in University of Thessaly).

NCT ID: NCT05144737 Active, not recruiting - Obesity Clinical Trials

A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program

Start date: November 21, 2021
Phase: N/A
Study type: Interventional

A pilot study titled "A Virtual Cardiometabolic Health Program for African Immigrants (The Afro-DPP Program) will be conducted to address the cardiometabolic of community-dwelling African immigrants who have multiple cardiometabolic risk factors including hypertension, Type 2 Diabetes, high cholesterol, and overweight/obesity. The proposed study will recruit a total of 60 participants and will use a non-equivalent control group design to test the effectiveness of the intervention at two African churches in the Baltimore, Washington, D.C. area. The two churches will be randomly assigned to the intervention or delayed intervention group. At the end of a 6-month follow-up period, the control church will receive the intervention (delayed control group). All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body composition including Body Weight, Body Fat percentage, Visceral Fat, Skeletal Muscle percentage, Resting Metabolism and Body Mass Index. A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will also be distributed to all participants. All participants will download the Omron Connect app which will allow the participants to sync participants' blood pressure readings and body composition readings into the app. The research team will access these readings to monitor study outcomes and participants progress during the follow-up period.

NCT ID: NCT05141565 Active, not recruiting - Depression Clinical Trials

The Kunshan Elderly Health Study

KEHS
Start date: May 17, 2021
Phase:
Study type: Observational

The Kunshan Elderly Health Study (KEHS) is a community-based prospective cohort study of chronic disease, mortality and associated factors among elderly adults in Kunshan, Eastern China.

NCT ID: NCT05120544 Active, not recruiting - Hypertension Clinical Trials

Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

EXTEND
Start date: April 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.

NCT ID: NCT05103306 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

LUCID
Start date: January 2017
Phase:
Study type: Observational [Patient Registry]

This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.