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Prediabetic State clinical trials

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NCT ID: NCT04875780 Recruiting - Pre-diabetes Clinical Trials

A Smartphone-based Intervention for Diabetes Prevention in Overweight Chinese Adults With Pre-diabetes

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

Type 2 diabetes (T2DM) is a serious chronic condition and one of the world's fastest growing health problems. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes, which provides an important window of opportunity for the prevention of T2DM and its complications. This project aims to translate the evidence-based diabetes prevention strategies into community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.

NCT ID: NCT04874415 Recruiting - Type 2 Diabetes Clinical Trials

Behavioral Economics for Activity Motivation in Adolescents (BEAM)

Start date: November 16, 2021
Phase: N/A
Study type: Interventional

There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a proposed mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.

NCT ID: NCT04873050 Recruiting - Pre Diabetes Clinical Trials

Treatment to Regress to Normoglycemia in Women With a Recent History of GDM

SWEET
Start date: January 13, 2022
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.

NCT ID: NCT04864860 Recruiting - PreDiabetes Clinical Trials

Effect of Sea Weed (Ecklonia Cava Extract) on Blood Glucose and Insulin Level on Pre-diabetic Patients

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

Introduction: The inhibition of α-amylase and α-glucosidase enzymes is suggested strategy for glycemic control particularly in people with prediabetes and diabetes. Polyphenola-rich brown seaweed extracts, have been proposed to have similar inhibition effect on α-amylases and α-glucosidases, thus improving diabetic related response. This proposal aims to investigate the effect of seaweed extract called E. cava on postprandial blood glucose (PPBG) and postprandial plasma insulin level (PPIL). Likewise, the study will examine any intolerance symptoms associated with the consumption of the studied seaweed extract. Objectives: Investigate the effectiveness of seaweed (E. cava) in reducing postprandial blood glucose and plasma insulin level in pre-diabetic patients, compared to placebo. Investigate the safeness and potential adverse effect of applying sea weed (E. cava) as a therapeutic diet composition on patient with pre-diabetes, compared to placebo. Methods: Double-blind, Randomized-controlled trial that will be conducted from 1st March 2021 to 20th July 2021 in Saudi Arabia. Participants will be eligible to participate in this study if they are diagnosed in their medical history as pre-diabetic patient through their medical records aged between 18 and 65 years with fasting plasma glucose (FPG) between 100 and 125 mg dL-1 as a set criterion by American Diabetic Association (ADA), and blood pressure within the normal range (systolic blood pressure ≤ 140 mmHg, diastolic blood pressure ≤ 90 mmHg set by World Health Organization (WHO) having no other health complications. Participants will be excluded if they are smoker, pregnant or lactation or having liver, thyroid, significant gastrointestinal disorders, taking any treatment with either insulin or anti-diabetic drugs or any other natural health products known to impact blood sugar. The number of individuals is required to detect differences of 38 units in BG and 2500-unit in plasma insulin (incremental under the curve (iAUC)) at 0.05 significance level with 80% power of the study. Study supplements (intervention and placebo) will be encapsulated in identical capsules and will be labelled with the letter A and B to conceal which supplement is given to participants each testing occasion. computer-generating randomization, data collection and analysis will be double-blinded. The intervention product used in this study is a dietary supplement capsules called "Seanol" that contain 13% pholoratannic polyphenol per capsule as stated by the manufacture company (seanol inside, 4215 95th St SW Lakewood, WA 98499 USA). Prior carbohydrates consumption, 2 capsule (1000 mg of E. cava), that contain 150 mg of pholorotanic polyphenol containing polyphenol will be administered at a single occasion for postprandial testing. This dose was selected to be similar to previous studies that shows no harm or sever adverse effect on participants (12, 14). placebo will be Similar in composition to the intervention. Plasma glucose concentration will be determined immediately by blood finger-prick sample following standard procedure using HemoCue Glucose 201 RT System (Radiometer Pacific Pty Ltd, Mount Waverley, VIC, Australia). Whereas, plasma insulin will be measured at the laboratory department at KKUH using enzyme-linked immunosorbent assay (ELISA) Statistics Mann-Whitney test will be used to determine differences for symptoms of intolerance between groups. Incremental area under the curve (iAUC), time to peak and peak blood concentration assessment will be used to assess postprandial responses of for plasma glucose and insulin level. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 20.

NCT ID: NCT04863235 Recruiting - PreDiabetes Clinical Trials

Examining the Impact of a Self-compassion Intervention on Physical Activity Behaviour Among People With Prediabetes

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

The investigators plan to examine whether teaching people at risk for type two diabetes to use self-compassion (orientation to care for oneself during difficult situations) helps them self-manage and increase their physical activity. People at risk for type 2 diabetes will learn about their type 2 diabetes risk and strategies to increase their physical activity, which represents the recommended information that people at risk for type two diabetes should receive. In addition to this, some participants, but not all, will be taught to be self-compassionate in relation to their type two diabetes risk and their efforts to increase their physical activity. The investigators expect that people who receive the additional training about how to be self-compassionate will engage in more physical activity than people who do not and they will do so because of self-compassion's positive effect on aspects of self-management - adaptive reactions and a tendency to use strong self-management skills. This study is important for health promotion because it allows the investigators to determine whether they can improve how they currently help people prevent type 2 diabetes through engaging in physical activity.

NCT ID: NCT04851223 Recruiting - Clinical trials for Type2 Diabetes Mellitus

Investigating Plasma Biomarker Molecules Associated With the Progression of Prediabetes to Overt Type 2 Diabetes

Start date: March 22, 2021
Phase:
Study type: Observational

There are an estimate 7 million people in the United Kingdom living with pre-diabetes. The increasing number of new cases of pre-diabetes presents a global health concern due to funding implications. The progression from pre-diabetes to overt type 2 diabetes is often characterised by a reduction in insulin secretion (or β-cell dysfunction). Whilst inflammation may contribute to β-cell dysfunction, a complete picture is still lacking. The proposed research will help develop a more complete understanding of the molecules that may trigger β-cell failure, a process that often connects pre-diabetes to overt diabetes. The aims of this project are; 1. Run large-scale proteomics and metabolomics analysis in pre-diabetic individuals to determine possible biomarker molecules. 2. Use measures and / or classifications of insulin resistance and diabetes (i.e. β-cell function and Disposition Index) to establish whether particular metabolic and / or proteomic signatures (aim 1) are associated with the development of pre-diabetes. 3. To determine if the possible metabolite or protein profile changes are associated with the progression or regression of pre-diabetes from baseline (0 month) to the end of the National Diabetes Prevention Programme (NDPP) (9 month).

NCT ID: NCT04799938 Recruiting - PreDiabetes Clinical Trials

Effect of Exercise on GDF-15 Levels in Prediabetic Patients

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate whether there is a change in GDF-15 levels in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program with guide-based exercise programs.

NCT ID: NCT04773834 Recruiting - Pre Diabetes Clinical Trials

Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program

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

This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient's use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and MyChart messaging.

NCT ID: NCT04765982 Recruiting - Diabetes Clinical Trials

Does Insulin Requirement Post Cardiac Surgery Predicts The Risk Of Developing Diabetes

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

The patient outcome in cardiac surgery is substantially linked to the occurrence of hyperglycemia. Qatar ranks 5th in the rate of diabetes globally; Moreover diabetics comprise more than 40% of patients admitted to the cardiac surgery intensive care unit (CTICU) in Qatar heart hospital. This prevalence is higher than the rest of the world. These numbers are projected to increase with accompanied morbidity-mortality hazardous by 2030 if the adequate intervention will not be directed towards better control of blood sugar within ICU and the hospital stay. The overall objective of this project is to explore the immunological profile in patients with poor glycemic control within their intensive care unit stay in Qatar. 'time in range' (TIR) was used for defining glycemic control within the ICU, where patients with time in range more than 80%, (in presence or absence of debates), had better outcomes than those with time in range less than 80% TIR. Notably, regarding wound infection, lengths of ventilation and ICU stay; they were not candidates to recurrent hypoglycemic episodes also. The high HbA1C preoperatively is probably a valid forecaster of indigent glycemic control. Previous studies demonstrated conversion of non-diabetics to diabetics when they face stress of critical illness. No previous studies explored this possible conversion cardiac surgery. Our primary objectives will be to determine whether non-diabetic patients with poor glycemic control in cardiac surgery would develop subsequent diabetes later on. Investigators will follow up non-diabetics patients after 3 months to satisfy this aim. Investigators will include all patients who will undergo cardiac surgery over two years from the time of approval without evidence of diabetes as documented by glycated hemoglobin (HbA1C). Patients will be followed up to one year with laboratory investigations to document whether they will develop diabetes or not. Data will be stored and statistically analyzed. Investigators expect to have details about the possible conversion in this high-risk population.

NCT ID: NCT04742751 Recruiting - PreDiabetes Clinical Trials

An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer

Start date: March 2, 2022
Phase: Phase 2
Study type: Interventional

This is a first-in survivor, single-arm pilot study with the goal of establishing evidence of feasibility and safety of a combined pharmacologic (metformin) and lifestyle intervention (using an existing digital platform) to prevent diabetes in prediabetic adult survivors of childhood cancer. Primary Objective The primary aim of this proposal is to establish the feasibility and safety of a 24-week combined metformin + intensive lifestyle intervention among adult survivors with prediabetes (including a 12-week lifestyle alone run-in followed by 12-week combined intervention among survivors remaining prediabetic). Primary endpoints of this trial will be adherence to 1) daily metformin administration and 2) completion of required core-curriculum of the lifestyle change intervention. Safety will be assessed using the Global Rating of Side Effects Burden Secondary Objectives The secondary aim is to assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on glycemic control and insulin resistance. Glycemic control will be measured by fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) and insulin resistance measured by the homeostatic model assessment (HOMA-IR) and IGF- binding protein 1 (IGF-BP1; a measure of insulin sensitivity strongly correlated with euglycemic insulin clamp testing). Exploratory Objectives To assess preliminary evidence for efficacy of the combined metformin + intensive lifestyle intervention on weight, other anthropometric measures, blood pressure and lipid profile, physical activity (self-reported and as measured by accelerometer), frailty measures, and health-related quality of life (HRQOL). We will also assess diabetes development at future SJLIFE visits. To assess measures of participation in the lifestyle change program as well as barriers to participation and medication adherence.