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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05261373 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Efficacy of a Nutritional Education Strategy and Physical Exercise on the Gut Microbiota in Type 2 Diabetics

EDUGUTION
Start date: March 10, 2022
Phase: N/A
Study type: Interventional

We hypothesize that the combination of a nutritional education intervention with a HIIT-based physical exercise program improve muscle metabolism through positive modifications of gut microbiota in people with T2DM, leading to better glycaemia/insulinaemia levels, reduction of body fat mass and improving quality of life. The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT. The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, faecal samples, blood samples, blood pressure, appetite assessment, muscle biopsy samples, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.

NCT ID: NCT05259449 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Efficacy of Educational Nutrition and Exercise on the Regulation of Appetite Through Exosomes in Type 2 Diabetics

APETEX
Start date: March 10, 2022
Phase: N/A
Study type: Interventional

We hypothesize that the combination of a nutritional education intervention with a physical exercise program improves appetite regulation mediated by exosomes in people with Type 2 Diabetes Mellitus (T2DM), leading to better glycaemia/insulinaemia levels, reduction of body fat mass and quality of life. The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT. The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, blood samples, emotional reactivity to food images, blood pressure, appetite assessment, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.

NCT ID: NCT05256875 Recruiting - Hypertension Clinical Trials

An Analysis to Assess Non-adherence in People With Type 2 Diabetes

Start date: August 30, 2022
Phase:
Study type: Observational

Non-adherence is defined as: "the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider". Non-adherence in chronic cardiometabolic diseases including diabetes is very common and is often the primary reason for treatment failure. This leads to significant excess costs to the health economy through avoidable investigations, treatment escalations, hospital admissions, and disease complications. Methods to diagnose non-adherence have until recently been poor. We have recently developed an objective and robust chemical adherence test to detect the presence of 160 cardiovascular medications in urine using high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Chemical adherence testing has not been utilised in people with diabetes, further its relationship with other measures of adherence is unknown. The main aim of this observational study is to compare chemical non-adherence with other commonly used measures of non-adherence in people with diabetes. Chemical testing for non-adherence will be performed using urine provided by 600 patients with poorly controlled diabetes attending primary care recruited over a 15-month period. Participants will also be required to complete a self- reported questionnaire and pharmacy records will be reviewed to ascertain prescription refill rates. The prevalence and metabolic control of non-adherence as diagnosed chemically will be compared with those obtained by pharmacy refill rates and patient self-reported questionnaires. Further, the determinants of non-adherence as ascertained by urine LC-MS/MS analysis will be studied. It is hoped that this innovative study will lead to further larger intervention studies that will change the management of non-adherence in diabetes.

NCT ID: NCT05256615 Recruiting - Diabetes Clinical Trials

Exercise Timing and Gestational Diabetes

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to understand if the timing of exercise around food intake can help improve blood sugar management in pregnant individuals with diabetes.

NCT ID: NCT05254496 Recruiting - Obesity Clinical Trials

The Dietary Guidelines 3 Diet Patterns Study (DG3D): Phase 2

DG3D-Phase2
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

Based on the findings of our formative work, conduct a one-year intervention among African American Adults using revised culturally tailored materials to examine differences in Healthy Eating Index (HEI) and type 2 diabetes (T2DM) risk factors among participants (n=198) randomized to one of the 3 dietary patterns: 1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern.

NCT ID: NCT05249881 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."

Start date: March 10, 2022
Phase: Early Phase 1
Study type: Interventional

A prospective interventional trial for 9 months will be carried out on 300 type-2 diabetes mellitus volunteer patients who are above 18-year-old and participants will be selected through consecutive sampling and will be evaluated on the basis of glycemic index and history of patients. Selected parameters will be measured at baseline and after the 12 weeks of therapy. Statistical analysis will be carried out by SPSS, ANOVA, and t-test. From this experimental design, we are expecting improvement in the management of glycemic index, reduction in systolic and diastolic blood pressure, and reduction in weight GLP-1 naive patients.

NCT ID: NCT05248412 Recruiting - Hypertension Clinical Trials

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases

Start date: June 21, 2021
Phase:
Study type: Observational

Objectives and aim: To evaluate the long-term spill-over (indirect) effect of Coronavirus disease (COVID-19) on health outcomes and healthcare utilization among people with non-communicable diseases and without COVID-19. Design: A population-based cohort study using electronic health records of the Hospital Authority (HA) clinical management system, economic modeling, and serial cross-sectional surveys on healthcare service utilization. Setting: HA public hospitals and outpatient clinics in Hong Kong Participants: People aged ≥ 18 years with a documented diagnosis of diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic respiratory disease, and chronic kidney disease; without COVID-19; attending HA services between 2010 and 2024. Main outcome measures: All-cause mortality, disease-specific outcomes, healthcare service utilization, and costs. Methods: The annual incidence of each outcome in each year between 2010 and 2024 will be calculated. An interrupted time-series analysis to assess the changes in outcomes between pre-and-post-COVID-19 outbreak periods. Long term health economic impact of healthcare disruptions during the COVID-19 outbreak will be modeled using microsimulation. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression to evaluate the effect of different modes of care on the risk of the outcomes. Implications: Findings will inform policies and practices on contingency care plans to avoid excessive morbidity and mortality and to assure the quality of care for patients with NCD as part of the territorial response to the health crisis.

NCT ID: NCT05234281 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)

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

The health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers. The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue. The concentrated interdisciplinary rehabilitation is characterised by three phases; 1. Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change 2. Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below) 3. Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living The concentrated intervention: The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely: - Initiate treatment when the patient is ready for change - Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices"). - Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others. - Use long sessions to ensure that they face a broad range of potential micro-choices - Work side-by side with others going through an analogous pattern of change - Prepare them for taking responsibility for integrating the change into every-day living Main outcomes will be 1. Completion rates 2. Patient satisfaction 3. Changes to perception of illness 4. Patient activation Secondary outcomes will be 1. Level of functioning 2. Qualitative description of participants' experiences

NCT ID: NCT05230589 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Saudi Arabia, as Part of Local Clinical Practice

PIONEER REAL
Start date: January 11, 2022
Phase:
Study type: Observational

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

NCT ID: NCT05228860 Recruiting - Obesity Clinical Trials

Addressing Diabetes by Elevating Access to Nutrition

ADELANTE
Start date: September 18, 2023
Phase: N/A
Study type: Interventional

The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes. Specifically, ADELANTE aims to 1. determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months, 2. examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and 3. assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.