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Prediabetic State clinical trials

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NCT ID: NCT04905485 Active, not recruiting - Diabetes Clinical Trials

Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

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

Participants who were previously Viome costumers who signed informed consent to participate and self reported type 2 diabetes or pre-diabetes were enrolled. They provided stool samples to VIOME and were provided with precision diet and supplement recommendations. The information obtained from this study is used to train a model to predict diabetes and/or risks of developing diabetes.

NCT ID: NCT04902326 Completed - Pre Diabetes Clinical Trials

Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)

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

Patients with prediabetes can significantly reduce their risk of developing type 2 diabetes mellitus (T2DM) by participating in a Diabetes Prevention Program (DPP) or using metformin, but very few patients with prediabetes engage in these strategies. This randomized controlled trial will compare, among adults with prediabetes, the effectiveness of financial incentives, tailored messages based on self-determination theory (SDT) principles, and the combination of financial incentives plus tailored messages based on SDT principles in decreasing hemoglobin A1c (HbA1c) and weight and in increasing participation in a DPP or use of metformin. Our main hypotheses are that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives generic health education messages, and that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives financial incentives alone and the arm that receives tailored messages alone. The study will also identify moderators and mediators of the effectiveness of the interventions and evaluate facilitators of and barriers to scalability, acceptability, and sustainability of the different interventions.

NCT ID: NCT04897945 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

Start date: October 12, 2021
Phase: N/A
Study type: Interventional

Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

NCT ID: NCT04881890 Completed - PreDiabetes Clinical Trials

Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes

VA LC-DPP
Start date: October 5, 2020
Phase: N/A
Study type: Interventional

The investigators will conduct a single-arm mixed methods pilot study to examine the feasibility and acceptability of a low-carbohydrate diabetes prevention program (LC-DPP). The investigators will estimate weight loss as well as the percentage of participants who achieve 5% body weight loss at 6 month and 12 month timepoints. Weight loss from the pilot VA LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies and the VA MOVE! program. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 12-month study period. The investigators will also conduct qualitative interviews with participants at 6 and 12 months.

NCT ID: NCT04881383 Active, not recruiting - Diabetes Mellitus Clinical Trials

Development and Validation of DM and Pre-DM Risk Prediction Model

Start date: April 1, 2020
Phase:
Study type: Observational

Many DM and pre-DM remain undiagnosed. The aim is to develop and validate a risk prediction function to detect DM and pre-DM in Chinese adults aged 18-84 in primary care (PC). The objectives are to: 1. Develop a risk prediction function using non-laboratory parameters to predict DM and pre-DM from the data of the HK Population Health Survey 2014/2015 2. Develop a risk scoring algorithm and determine the cut-off score 3. Validate the risk prediction function and determine its sensitivity in predicting DM and pre-DM in PC Hypothesis to be tested: The prediction function developed from the Population Health Survey (PHS) 2014/2015 is valid and sensitive in PC. Design and subjects: We will develop a risk prediction function for DM and pre-DM using data of 1,857 subjects from the PHS 2014/2015. We will recruit 1014 Chinese adults aged 18-84 from PC clinics to validate the risk prediction function. Each subject will complete an assessment on the relevant risk factors and have a blood test on OGTT and HbA1c on recruitment and at 12 months. Main outcome measures: The area under the Receiver operating characteristic (ROC) curve, sensitivity and specificity of the prediction function. Data analysis and expected results: Machine learning and Logistic regressions will be used to develop the best model. ROC curve will be used to determine the cut-off score. Sensitivity and specificity will be determined by descriptive statistics. A new HK Chinese general population specific risk prediction function will enable early case finding and intervention to prevent DM and DM complications in PC.

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: NCT04869917 Enrolling by invitation - PreDiabetes Clinical Trials

Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

BEGIN
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.

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.