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Prediabetic State clinical trials

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NCT ID: NCT05704309 Enrolling by invitation - Diabetes Clinical Trials

The Diabetes Prevention Program Outcomes Study AD/ADRD Project

DPPOS-4
Start date: November 7, 2022
Phase:
Study type: Observational

The DPPOS AD/ADRD project will address the overarching question: What are the determinants and the nature of cognitive impairment among persons with pre-diabetes (PreD) and type 2 diabetes (T2D), who are a high-risk group for cognitive impairment and represent a large fraction of the United States (US) population? This U19 proposal addresses the National Alzheimer's Project Act goal to "prevent, halt, or reverse AD" in the high-risk group of persons with pre-diabetes and type 2 diabetes, who represent over half of the population aged 60 years and older in the US.

NCT ID: NCT05701813 Not yet recruiting - Obesity Clinical Trials

The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.

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

The study aims to investigate the effects of oral inositols on insulin-resistance and metabolic variables (triglycerides, total cholesterol, HDL cholesterol) in children aged 8-12 years with obesity and insulin-resistance.

NCT ID: NCT05695170 Completed - Clinical trials for Overweight and Obesity

Couple-Based Lifestyle Intervention to Prevent Type 2 Diabetes

Start date: December 14, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized pilot clinical trial is to describe the feasibility of a couple-based lifestyle intervention and the study protocol in preparation for a future definitive randomized clinical trial. Participants include individuals at risk for type 2 diabetes and their romantic partners. The main objectives are: 1. To describe the feasibility of the couple-based intervention. 2. To describe the feasibility of the study protocol for use in a definitive trial. Participating couples will be randomized to one of two year-long lifestyle intervention conditions: an individual curriculum or a couple-based curriculum. Participants will complete assessments before and after the year-long intervention, as well as monthly during the intervention. Data will be collected on: feasibility, background, health behaviors, physical and mental health, and relationship functioning.

NCT ID: NCT05694351 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Family-based Prevention of Diabetes Through Eating Habits and Physical Activity

GO_EASY
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Introduction: Type 2 diabetes represents a growing health risk for the society. An easy-access and low-cost intervention for the whole family will be developed to help families with (at risk of) type 2 diabetes maintain diabetes-frendly everyday life. The intervention will be tested for feasibility. Methods: Following the framework for developing and conduct of complex interventions, the intervention will be developed on the basis of current evidence on family-based diabetes treatment and opinions of families with type 2 diabetes. The feasibility test will have embedded mixed methods one-group study design. Participants: Families will answer a brief screening questionnaire. Families (n=25) that consist of at least one adult with (in risk of) type 2 diabetes living in the same household with at least one 5-18 yeard old child, and at least one family member living sedentary lifestyle, will participate. Intervention: The 3-months long hybrid telehealth/face-to-face intervention with weekly 1-hour contacts with health professionals will deliver diabetes education and tailored support to implement more physical activity and healthy meals in the family everyday life. A 3-months long supervised maintenance phase with monthly professional contacts will be included. Outcomes: Feasibility evaluation will be conducted using quantitative (quantifiable) and qualitative research methods. The feasibility data will be the primary outcomes of the study, collected and evaluated using the predefined research progression criteria applied the green-amber-red method. Sociodemography and secondary outcomes, such as physical activity, dieting habits, daily occupations, occupational balance, health and quality of life will be assessed at baseline and 3 and 6-months follow-ups. The quantitative results will be comprehended through qualitative data from participant interviews which will nuance the feasibility evaluation. Analysis: Relevant statistical methods and qualitative analysis method will be applied. Expected results: The intervention will help families achieve sustainable lifestyle changes, e.g., diabetes stabilized blood glucose in adults with type 2 diabetes, increased physical activity time and improved dieting habits, for better family health and well-being. Ethics and dissemination: The trial does not have any obvious health risks for the participants. All the results - significant, non-significant and/ or inconclusive - will be reported.

NCT ID: NCT05689658 Completed - PreDiabetes Clinical Trials

Brazilian Diabetes Prevention Program: Pilot Study

PROVEN-Dia
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

To structure a Brazilian Diabetes Prevention Program based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS) and evaluating its effectiveness in a multicentric randomized clinical trial with 220 pre-diabetic patients and a follow up of 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.

NCT ID: NCT05668819 Recruiting - PreDiabetes Clinical Trials

Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

Start date: February 9, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.

NCT ID: NCT05662189 Recruiting - type1diabetes Clinical Trials

Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus

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

The goals of this project are to build an experimental tool to dissect out in vivo pancreatic beta cell mass (BCM) and beta cell function (BCF) and to assess for the first time these two determinants of beta cell functional mass (BCFxM) in obesity and in various stages of type 1 and type 2 diabetes mellitus.

NCT ID: NCT05658770 Not yet recruiting - PreDiabetes Clinical Trials

Efficacy of Physical Exercise on Glucose Control in People With Prediabetes (GLYCEX) - Phase II

GLYCEX
Start date: September 2, 2023
Phase: N/A
Study type: Interventional

Aim: To assess the efficacy of different frequencies of physical exercise on glycaemic control in adults with prediabetes. Methods: parallel, randomised, controlled, clinical trial will be carried out, with a total of 90 participants. Exercise modality that showed the best glycaemic control in first phase of GLYCEX study (NCT05612698) will be used. Participantds will be randomised in 3 groups: 1) frequency of 5 days/week, 2) frequency of 3 days/week and 3) frequency of 2 days/week. Data collection will be performed at baseline and after 15-weeks of follow up. Sociodemographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, in two time points. The main dependent variable will be the reduction of the mean amplitude of glycaemic excursions. The impact of the interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. Discussion: The results of this study will contribute to better understanding of the response of glucose mechanisms to physical exercise in a population with prediabetes as well as improving physical exercise prescriptions for diabetes prevention. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.

NCT ID: NCT05654727 Completed - Clinical trials for Cognitive Impairment

Cognitive Functions and BDNF in T2DM and Prediabetes Patients

Start date: July 1, 2021
Phase:
Study type: Observational

Clinical and epidemiological studies suggest links between cognitive impairments and Type 2 diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive impairment are largely unknown. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.

NCT ID: NCT05654142 Recruiting - Obesity Clinical Trials

The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older

PIVOT
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

This is a multisite clinical trial of healthy lifestyle programs for middle-to-older-aged adults (50 -74 years) to improve their weight and, therefore, reduce risk for chronic disease. This study will investigate whether a proven, self-directed video-based lifestyle program can be significantly enhanced with the assistance of a coach via videoconference or phone to help people as they adopt healthy eating and exercise behaviors. Additionally, the study will examine what factors might explain why some people achieve better outcomes than others. Understanding this can help to tailor the program to an individual for personalized care in the future. Importantly, this study aims to demonstrate how readily a digital lifestyle program, with or without remote coaching, can be seamlessly delivered to patients at home via the patient portal of their electronic health record. This practical use of existing telehealth tools could be a feasible and effective means to offer behavioral treatments during routine medical care.