Pre-diabetes

The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min/week), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.

7-Ketolithocholic Acid, a naturally occurring bile acid, is a novel food currently under investigation for potential metabolic benefits, including glucose-lowering effects. This study aims to evaluate the efficacy and safety of 7-Ketolithocholic Acid, administered alongside a low-glycaemic, hypocaloric diet, and increased physical activity in reducing fasting plasma glucose and other metabolic parameters in subjects with prediabetes. Demonstrating a clinically meaningful glucose-lowering effect would support its potential role in early intervention to prevent or delay the onset of type 2 diabetes.

The goal of this hybrid Type 1 effectiveness-implementation trial is to test the extent to which a peer support and community resource navigation intervention improves psychological well-being, addresses non-biologic drivers of health (access to healthcare, supportive services, nutrition, housing stability, transportation, chronic stress, social support), and thus reduces cardiometabolic risk among rural, low-income farmworker women aged 18-50 years. The main questions it aims to answer are: * If and to what extent does the intervention reduce stress, social isolation, and psychological distress by improving social support and access to needed resources? * If and to what extent does the intervention improve cardiometabolic health, measured by the American Heart Association's Life's Essential 8 (LE8) score? Researchers will compare the CHW-led Sisters for Heart Health intervention to a Basic intervention (LE8 assessment and resource information) to assess the effect of peer support and community resource navigation on heart health outcomes.

Individuals with lactase non-persistence (LNP; determined by a functional variant in the LCT gene \[rs4988235, GG genotype\]) are susceptible to lactose intolerance in adulthood due to deficiency of lactase, the enzyme which digests milk lactose sugars. However, many LNP individuals still drink ≥1 cup of milk daily. Recent analysis in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) found that consumption of 1 serving (cup) of milk/day was associated with \~30% lower risk of type 2 diabetes among LNP individuals, but not among individuals with lactase persistence (LP). This beneficial effect might be partially explained by favorable alterations in gut microbiota and related metabolites associated with higher milk consumption among LNP individuals. Based on these observational study findings, the investigator team proposes to conduct a randomized, controlled trial of lactose-containing vs. lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.

This is an open-label, prospective, multicenter observational study designed to evaluate the perceived benefits, device experience, preference, and glucose-related parameters associated with the Instara-1 Continuous Glucose Monitoring device. The study will include patients with diabetes and healthcare professionals. Patients will use Instara- 1 and will be followed up to assess device experience, glucose parameters, and diabetes-related quality of life. Healthcare professionals will evaluate device experience and preference, including comparison with FreeStyle Libre 2.

Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.

This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Participants with prediabetes will undergo both home-based and clinic-based OGTTs, with glucose levels measured via CGM and venous plasma glucose. The primary outcome is the correlation between CGM-based glucose values and standard OGTT results. Secondary outcomes include diagnostic agreement, metabolic hormone associations, and feasibility of home-based testing as a diagnostic tool for dysglycemia.

Prediabetes is a condition wherein blood sugar levels are elevated but not sufficiently high enough to diagnose type 2 diabetes mellitus (T2D). Prediabetes is a critical risk factor for the development of T2D in pediatric populations. This progression can occur over a short period of time, limiting the efficacy and impact of existing interventions and recommendations targeting this population. There is growing evidence on the use of continuous glucose monitors (CGMs) in adult prediabetic populations to prevent the development of T2D, though this intervention has not been thoroughly investigated in pediatric populations. The investigators are proposing a pilot study of 25 prediabetic adolescents enrolled in a 20-week study. For the initial 10 weeks of the study, the participants will go without CGMs and undergo clinically recommended education on their condition as standard of care. In the 10 weeks following, participants will be given a CGM to wear and instructions on its use. Surveys will be issued to all participants over the entirety of the study to follow behaviors surrounding food and physical activity.

This randomized study will be conducted to compare the effect of a healthy beef-centric diet to a healthy U.S.-style dietary pattern on inflammation and other metabolic health outcomes in a metabolic syndrome and/or pre-diabetic population.

More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial. The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses. The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).

Cardiovascular disease is the leading cause of death worldwide, and individuals with diabetes or other cardiometabolic conditions are at increased risk of adverse cardiovascular outcomes. Although advances in prevention and treatment have reduced cardiovascular events globally, cardiometabolic disease continues to represent a significant health burden, particularly in regions with high diabetes prevalence. In Qatar and other Gulf Cooperation Council countries, the prevalence of diabetes and obesity is increasing, contributing to a high proportion of participants presenting with acute coronary syndrome who have type 2 diabetes or prediabetes. This observational study will use electronic medical record data from patients hospitalized at the Heart Hospital with acute coronary syndrome and a concomitant diagnosis of diabetes or prediabetes. The study will assess trends in cardiovascular risk factors and cardiovascular events, including readmission and mortality. An artificial intelligence component will be used to develop and validate machine learning based risk prediction models to forecast adverse cardiovascular outcomes in participants with cardiometabolic disease. These models will integrate clinical, biochemical, imaging, and other non-invasive data routinely collected during participants care to identify predictors of cardiovascular events.

This study is to investigate how adipocyte (fat cell) function and fat distribution differ between individuals with normal-weight type 2 diabetes (NWD), those with overweight type 2 diabetes (OWD), and normal-weight controls without diabetes (NWC). The study will assess whether adipocyte-directed therapies, specifically pioglitazone and tirzepatide, can improve insulin resistance, adipocyte function, and fat distribution in individuals with NWD. By analyzing the biological mechanisms underlying adipocyte dysfunction, the study aims to provide insights into novel treatment strategies for improving metabolic health in normal-weight individuals with type 2 diabetes.

The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.

The goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE. The investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English. The primary feasibility measure is acceptability, as measured by intervention session attendance. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi, where study staff will assess weight, hemoglobin A1c, diet, and physical activity.

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

In a randomized controlled trial, the investigators intend to measure the health impact of time restricted eating (TRE) in patients with metabolic syndrome (with elevated blood pressure and at least 2 of the following: increased waist circumference, abnormal cholesterol levels, elevated triglycerides, and elevated fasting glucose levels), who habitually eat more than 12 hours every day. Patients will be randomly assigned to a control group (standard of care) or intervention group (TRE).

The goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes. The investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. The results from this study has the potential to impact clinical practice and patient care.

Part 1 and 2 of study (For Patient Participants) The purpose of this study is to examine if the wearing of a medical device called a continuous glucose monitor (CGM) can guide adults with prediabetes modify their behaviors and manage their health, compared to traditional health coaching. Prediabetes means the study participants have a higher-than-normal blood sugar level which is not high enough to be considered type 2 diabetes yet but will put them at risk of developing it. CGM measures glucose levels without the participants having to prick fingers and involves wearing a small sensor on the back of the arm day and night which allows viewing of glucose levels on the mobile phone with a painless 1 second scan. This is the first time the investigators are trying to do research using CGM for adults with prediabetes. the study team want to learn how practical it is to do such a study. The study will explore if wearing of a CGM sensor makes a difference in terms of health outcomes compared to regular health coaching. It also aims to understand the users' experience with the CGM system. This study targets to recruit 76 participants from Pasir Ris Polyclinic. Part 1 of the study uses a research method called a randomized controlled trial. Participants who consent to join will be allocated to one of two groups based on chance. Half of the participants will receive the CGM sensor in addition to health coaching. This is called the intervention group. The other half of the participants will receive health coaching alone. This is called the control group. Participants in both groups will continue regular follow-up with their own primary care physicians. There will be 3 study touchpoints, which will mainly be at Pasir Ris Polyclinic. 1. Baseline visit: * Receive health coaching that will take 20-30 minutes. * Complete questionnaires about socio-demographic details, diet and physical activity which will take 20-30 minutes. * Measure weight, body mass index (BMI), and waist circumference. * Past medical history and medications will be retrieved from the electronic medical records. * If the participants are in the intervention group, the study team will assist them to apply the Abbott Freestyle Libre continuous glucose monitoring (CGM) sensor and link it to their smartphone. The study team will also set up the LibreLink app and Libreview account. 2. 1-month touchpoint * Complete follow up questionnaires to assess any changes in the diet and physical activity. * This touchpoint may be conducted either face-to-face or via a phone call. 3. 6-month touchpoint * Complete final questionnaires about the lifestyle. * Measure weight, BMI and waist circumference again * Uninstall the LibreLink app and Libreview account. Part 2 of the study is an in-depth interview to understand the experiences of the participants using the Abbott Freestyle Libre CGM System. This part of the study will be conducted either during the 3rd study touchpoint or on another day (within 9 months from start of intervention). The interview will last 60 minutes and will be audio-recorded. Questions asked will be regarding the general experience using the CGM, any difficulties with following the study instructions and suggestions to improve the study. Part 3 of study for Healthcare Providers Participants (HCP): The purpose of this study is to assess the effects of CGM on adults with prediabetes and to explore the facilitators and barriers of using CGM in prediabetes management from both patients and healthcare providers. The study aims to understand the perspectives of primary care providers on the potential benefits, challenges, and feasibility of integrating CGM into prediabetes management. The findings will help pave the way for broader integration of CGM technology into public health programs targeting specific populations at high risk of diabetes to improve health outcomes. If the participants agree to participate, they will be invited to fill in a data collection form on the demographics, qualifications and clinical experience. This will take 20-30 minutes. The participants will be interviewed either individually or in a group with other of their colleagues from the same polyclinic. During the interview, the researcher will ask questions pertaining to their experiences with prediabetes management, knowledge of CGM and their views of the potential challenges and opportunities in the utilization of CGM by prediabetic adults. The interviews will be audio recorded. participation in the study will last approximately 60 minutes.

The goal of this study is to find out if adding electronic medical record (EMR) prompts helps prevent people with pre-diabetes from developing diabetes. It will also look at how these prompts affect doctor and patient behaviors. The main questions are: Does it improve follow-up care, such as blood tests, referrals, and medication? Does the EMR prompt reduce the number of patients who progress to diabetes within six months? Researchers will compare clinics that use EMR prompts with clinics that do not. Participants will: Receive usual care for pre-diabetes at their polyclinic In some clinics, doctors will see EMR prompts suggesting tests, referrals, and medication Complete surveys about their health and lifestyle at different time points

The aim of this study is to evaluate the role of the triglyceride-glucose (TyG) index as a predictive marker for insulin resistance in pre-diabetic patients with chronic kidney disease (CKD), and to investigate its potential utility as a simple, non-invasive alternative to traditional insulin resistance assessment methods.

The purpose of INNODIA DETECT is to identify people who are at increased risk of developing T1D. Investigators are doing this by testing for markers in the blood (autoantibodies) that tell them an individuals risk of getting T1D in the future. What is Type 1 Diabetes (T1D)? T1D is a serious disease where the blood glucose (sugar) level is too high because the body cannot make a hormone called insulin. This happens when the body's immune system attacks the cells in the pancreas that make insulin (called beta cells), meaning that insulin production stops. This is harmful to the body as insulin does an essential job. It allows the glucose in the blood to enter cells and fuel the body, resulting in a lowering of the blood glucose level. What are Autoantibodies? T1D autoantibodies are markers found in the blood that indicate that the destruction of insulin producing cells has begun. The risk of developing T1D increases with the number of autoantibodies detected. People who have 1 autoantibody detected in their blood are at increased risk of developing T1D. The presence of 2 or more autoantibodies indicates that T1D is present but the individual does not show any signs or symptoms yet. However, these autoantibodies can be present for many years before someone develops symptoms of T1D. They often appear in the first few years of life. The investigators are asking children and adults across Europe, aged between 1 and 45 years, who have either a family member (parent, child, full or half sibling) or close friend diagnosed with T1D before 45 years of age to provided a small blood sample so they can look at these T1D autoantibodies. If a participant's autoantibody results are negative, this means they do not have autoantibodies and are at low risk of developing T1D. No further tests will be required, and they will exit the program. If results indicate a participant has 1 or more positive T1D autoantibodies, a member of the clinical team will contact and invite them to the hospital for a venous blood sample to confirm the result. This confirmation test will be done as part of routine clinical care by the participants clinical team. INNODIA DETECT will end here and, if confirmed positive, the participant will be invited to attend further follow-up by entering in a separate protocol (named INNODIA MONITOR).

The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.

Pre-diabetes (Pre-D) is a precursor to type 2 diabetes (T2D) and characterized by increased exercise fatigability of lower limb muscles, that can impede exercise performance. The cause for the increased fatigability in people with Pre-D is not known. Given the profound vascular disease present in people who have had uncontrolled diabetes for several years, we will determine whether dynamic, fatiguing contractions of the lower limb muscles in people with Pre-D are limited by vascular dysfunction at multiple levels along the vascular tree including the artery, arteriole, and/or capillary. This clinical trial involves a novel exercise training regime involving blood flow restriction to the exercising limb will be used as a probe to further understand the vascular mechanisms for increased fatigability in people with Pre-D and T2D. The long-term goal is to better understand what limits exercise and functional performance in people with diabetes to help develop targeted, more effective exercise programs.

There is limited research on the impact of millets on glycemia, and it remains unclear whether partially replacing wheat in rotis with low glycemic index millets or Bengal gram flour offers greater glycemic benefits compared to whole wheat. This approach has the potential to reduce postprandial and overall glycemia, supporting the reversal of prediabetes through dietary modification alone. This study introduces a novel formulation of rotis using 50:50 blends of wheat with either barnyard millet, barley, or Bengal gram flour, aiming to improve glycemic control without compromising taste. Glycemic response is assessed through a combination of meal tolerance tests, continuous glucose monitoring, and a three-month dietary intervention, providing both immediate and long-term data. Additionally, the study includes a comprehensive metabolic evaluation by measuring serum insulin, inflammatory markers, and free fatty acids key indicators in the progression of prediabetes. Conducted as a randomized controlled trial with 80 participants across four arms (20 per arm), the study comprises three phases: Phase I evaluates immediate glycemic response through a meal tolerance test; Phase II uses continuous glucose monitoring over three days to monitor fluctuations in glucose levels; and Phase III, with 140 participants, assesses the long-term impact of the dietary intervention over three months. The primary objectives are to determine the effect of the interventions on glycemic response and HbA1c, with an expected outcome of a 10% reduction in the area under the curve for overall and postprandial glucose in Phases I and II, and a 10% reduction in HbA1c in Phase III.

Type 1 diabetes (T1D) is a life-long condition where the immune system destroys part of the body (the pancreas) which makes the chemical, insulin. Insulin is needed to control blood sugar levels. Treatment involves life-long insulin replacement by injection or insulin pump. Previous research has shown that the development of T1D occurs through different stages. This starts with a phase where there are no symptoms, which can last months or years, before symptoms of T1D develop and a person becomes unwell. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies (IAb). Children with two or more IAb have an 80-90% chance of developing T1D within 15 years. It is almost certain that they will develop the condition in their lifetime. Children with only one IAb have a much lower risk of developing T1D (around 15%). Less is understood about the natural history of being IAb positive in adults, and the investigators hope this study will help them understand more. The aim of the research is to understand what it is like to live with being at risk of T1D, what information and support people need, and whether they use NHS services more than others, for example due to being anxious about developing T1D. The investigators will work with the public and patient involvement group using information from the research and, with the charity Diabetes UK, to create a policy statement about the type of care that is needed to support these individuals. To be able to do this research, tbhe investigators need first to recruit these rare individuals into one single registry of children, young people and adults who have islet autoantibodies in their blood. This will also allow the invetigators to collect data from individuals in the registry to compare this to data from other countries, to help understand why people progress from being islet autoantibody positive to requiring insulin in the UK. People entering the registry will also be told if a drug is licensed in the UK to help delay T1D onset. Participants can also consent to be contacted about any research studies, which are testing drugs or interventions to prevent or delay the start of T1D.