Clinical Research Directory

Food Sequencing in Food Insecurity

The purpose of this study is study the impact of meal sequencing when added to standard care in individuals with diabetes mellitus/prediabetes who receive produce boxes as part of a food insecurity program. Meal sequencing is a way of eating where proteins and vegetables are consumed before carbohydrates. Eating proteins and vegetables first has shown to cause lower post meal glucose levels compared to eating carbohydrates first in a meal. The investigators believe participants with prediabetes or diabetes mellitus experiencing food insecurity enrolled in a produce delivery program and receive meal sequencing counseling will have improvement in glucose levels and dietary quality compared to those who are enrolled in the produce delivery program and receive standard nutritional counseling.

Training Induced Muscle-Adipose EV Communication

This study examines how muscle cells communicate with fat cells through tiny packages called extracellular vesicles (EV) during exercise. These vesicles carry important molecules that may affect how the body processes sugar and fat. The research team observed significant variability in the adipose response to exercise, and used this variability to gain further insight into the mechanism through which mature microRNA-1 (miR-1) changes in adipose tissue. The investigators selected six subjects with the highest increase in miR-1 abundance in adipose tissue after exercise and compared them with the six subjects that had the most dramatic decrease in miR-1 abundance after exercise. The research team observed that participants intrinsically vary in their ability to endocytose EV into adipose tissue. It is unclear whether this variance in receptivity is a cause or consequence of the significant difference in EV-delivery of miR-1 to adipose tissue.

Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes

The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are: * Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes? * Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes? Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes. Participants will: * Complete surveys at the beginning of the study and up to 2 additional surveys * If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.

Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults

We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.

Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes

This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel health, insulin sensitivity, and exercise capacity in individuals with prediabetes. We will be comparing the responses in individuals who are taking metformin to those who are naive to metformin. The results from this study may help identify non-pharmacological interventions in prediabetes.

Effects of Postprandial Walking and Resistance Snacking on Glucose Responses in Adults With Metabolic Syndrome

This study will examine whether light physical activity after meals can improve 24-hour glucose responses in adults with metabolic syndrome and prediabetes. Participants will complete three experimental conditions in a randomized crossover order: prolonged sitting, 15 minutes of postprandial walking, and brief resistance exercise snacks consisting of squats and calf raises performed every 20 minutes during the postprandial period. Continuous glucose monitoring will be used to assess 24-hour glucose responses, and heart rate variability will be measured during the 2-hour postprandial period to evaluate acute autonomic responses. The main outcome is 24-hour mean glucose derived from continuous glucose monitoring.

Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes

Non-healthy eating habits and a lack of exercise contribute to prediabetes and type 2 diabetes (T2D). Evening snacking is linked to abnormal weight gain in adults and healthy adolescents. Most adolescents do not get enough exercise. This study aims to look at the benefits of more exercise and stopping evening snacking in youth with prediabetes. The study lasts 8 weeks, and participants will be randomly assigned to either an intervention group or a standard of care group.

Personalized Meal Timing and Walking Based on Glucose Patterns in Adults With Prediabetes

This study will test whether glucose sensor data can be used to identify the time of day when adults with prediabetes are most likely to have high blood sugar after meals. Participants will first wear a continuous glucose monitor and wrist activity monitor and record meal times for 10 days. These data will be used to classify each participant's personal "glycemic vulnerability window," such as morning, evening, or generally variable patterns. Participants will then be randomly assigned to either personalized meal timing plus a short walk after their most vulnerable meal, or to an attention-matched control group receiving sleep hygiene and general step-count advice. The main outcome will be the change in post-meal glucose exposure during each participant's vulnerable window after 4 weeks.

Fiber mHealth Intervention for Prediabetes

This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber foods, and use of continuous glucose monitors.

Cardiometabolic Effects of Pecan Snacking in Prediabetes

The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

TREAT to Improve Cardiometabolic Health

Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

This study aims to employ a cluster randomized controlled trial to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight/Obese Individuals with Cardiometabolic Preconditions, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.

Effects of Dried Whole Fruits on Metabolism in Diabetes

Diabetes becomes epidemic in worldwide countries. Diabetes Canada indicated that 30% of adults in Manitoba are diabetes or prediabetes. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have certain side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Previous studies in the investigator's group demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The findings of the glucose and lipid lowering or liver protective effects of SB powder have been supported by another group in Australia in high fat fed rats. Preliminary studies by the investigators in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota The combination of findings suggest that SB is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in diabetic subjects. The investigators propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in untreated prediabetes and new type 2 diabetic patients compared to a control dried fruit in a randomized controlled trial.

Basic Carbohydrate Counting in Prediabetes

Type 2 diabetes mellitus (T2DM) is a major global health problem with rapidly increasing prevalence. Prediabetes represents a high-risk state for developing T2DM and is often asymptomatic, delaying diagnosis and intervention. Early identification and effective lifestyle interventions are essential to prevent or delay the progression to diabetes. Primary care settings provide an important opportunity for screening and implementing preventive strategies. Lifestyle modification, including dietary changes and physical activity, is the cornerstone of diabetes prevention. Carbohydrate counting is a medical nutrition therapy widely used in diabetes management and has been shown to improve glycemic control. However, there is limited evidence regarding its effectiveness in individuals with prediabetes. This study aims to evaluate the effect of basic carbohydrate counting education on HbA1c levels in individuals with prediabetes in a primary care setting. This randomized controlled trial will be conducted in the Family Medicine outpatient clinic of Marmara University Hospital. Individuals aged 18 years and older with HbA1c levels between 5.7% and 6.4% will be included. Participants will be randomized into intervention and control groups in a 2:1 ratio. The control group will receive standard lifestyle recommendations, while the intervention group will receive additional structured basic carbohydrate counting education in three sessions. HbA1c levels will be measured at baseline,at third and at 6 months. Secondary outcomes include body weight, body mass index, waist circumference,lipid panel and carbohydarte counting knowledge scale The findings of this study are expected to contribute to the development of effective, scalable, and practical nutritional interventions for diabetes prevention in primary care

Blood Glucose Screening in Patients With Advanced Periodontits: the Role of Specialist Periodontal Care in Identifying Hyperglycaemia and Supporting Patient Centered Treatment

Periodontitis is a chronic inflammatory disease and individuals with advanced periodontitis have an increased risk of hyperglycaemia. Bacterial plaque, smoking and elevated blood glucose levels are considered key modifiable risk factors for periodontal disease progression. Conventional periodontal care aims to remove and control bacterial deposits and to smoking cessation. Despite the bidirectional relationship, where periodontitis may also contribute to impaired glycaemic control, glycaemic status is rarely niether assessed nor adressed in dental care. The aim of this project is to implement and evaluate routine blood glucose testing as part of the periodontal examination in specialist dental care. Patients diagnosed with advanced periodontitis (Stage III or IV according to the current classification) will be offered capillary blood glucose testing during their periodontal assessment. The objectives of this study are to determine the prevalence of hyperglycaemia among patients with advanced periodontitis and to evaluate clinician-reported and patient-reported experiences of routine blood glucose testing as part of the periodontal assesment in specialist periodontal care.

Study EHR Risk Stratification Tools

This study evaluates whether adding machine learning-based risk information to electronic health record (EHR) lab result messages helps older adults better understand their risk of developing diabetes and influences their emotional responses, quality of life, and healthcare use. Eligible participants are adults aged 65 years and older with a UCLA primary care provider and a hemoglobin A1c level in the range (5.7-6.0%). Participants are identified automatically at the time their lab results are processed and are randomly assigned to receive either standard lab result messages or modified messages that include a "very low risk" label generated by a machine learning model. All participants who are randomized are invited to complete two surveys: one shortly after their lab result is posted in MyChart and a follow-up survey approximately 30 days later. The study also uses de-identified EHR data to examine patterns of healthcare utilization and progression to diabetes. Provider comments related to lab result messaging will be analyzed to explore differences in response patterns between the two groups.

Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial

This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.

The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults

Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited. This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.

Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Chiglitazar Sodium combined with lifestyle intervention for reversing prediabetes to normal glucose metabolism. Eligible participants with prediabetes will be randomized 1:1 to receive either Chiglitazar Sodium 48 mg once daily or matching placebo, both combined with standardized lifestyle intervention, for 52 weeks, followed by a 12-week observation period and optional long-term extension. The primary endpoint is the reversion rate to normal glucose metabolism at week 64. Secondary endpoints include progression to type 2 diabetes, glycemic control, lipid profile, blood pressure, UACR, HOMA-IR, HOMA-β, body weight, BMI, and waist-to-height ratio. Exploratory endpoints include inflammatory markers and long-term cardiovascular outcomes. Safety endpoints include adverse events, vital signs, ECG, and laboratory parameters.

Preventive Nutritional Supplements for Preclinical Pathologies

The main objective of this intervention study was to evaluate the functionality of a multi-target preparation (rich in phloretin from apple, chromium picolinate, zinc, magnesium and cinnamon extract) on the glucose response of individuals who show factors associated with prediabetes.

Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?

Brief Summary The goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in brain energy use and thinking speed compared to older adults with normal blood sugar levels. The study will also test whether a single dose of an exogenous ketone supplement can improve brain energy use and cognitive processing speed. The main questions it aims to answer are: Do older adults with prediabetes have lower brain glucose uptake and slower cognitive processing speed compared to those with normal glucose levels? Does a single dose of an exogenous ketone monoester supplement improve cognitive processing speed and brain glucose uptake? Researchers will compare older adults with prediabetes to older adults with normal glucose levels to determine whether differences exist in brain glucose metabolism and cognitive performance. In a subset of participants, researchers will also compare brain and cognitive outcomes before and after consuming a ketone monoester supplement (DeltaG, Oxford, England). Participants will: Complete metabolic testing to determine glucose status Undergo brain imaging using fluorodeoxyglucose positron emission tomography combined with magnetic resonance imaging (18FDG-PET/MRI) while performing a cognitive processing speed task Consume a single dose of a commercially available ketone monoester supplement during one study visit Complete cognitive testing during imaging to measure processing speed and brain activity The results of this study will help determine whether early metabolic dysfunction is linked to reduced brain energy use and whether ketones can temporarily support brain function in individuals at risk for dementia.

Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes

Prediabetes significantly increases the risk of developing diabetes, cardiovascular and cerebrovascular diseases, tumors, and dementia. Early identification and intervention have become a leading focus in current diabetes prevention and control research. Currently, prediabetes screening primarily relies on methods such as fasting blood glucose, oral glucose tolerance tests, and glycated hemoglobin. These approaches suffer from limitations including single-point assessment, static nature, cumbersome procedures, poor reproducibility, delayed diagnosis, and limited accuracy. Continuous glucose monitoring (CGM) technology offers advantages such as ease of use, dynamic continuous monitoring, and round-the-clock surveillance. It comprehensively captures glucose fluctuation patterns, enabling identification of occult hyperglycemia and glucose variability. Integrating artificial intelligence (AI) to perform deep analysis on CGM-generated big data holds promise for pioneering new pathways toward earlier and more precise identification of prediabetes. This project aims to establish a prospective prediabetes cohort integrating multidimensional data-including CGM parameters, body composition analysis, clinical indicators, and biomarkers-to develop novel diagnostic models for prediabetes. Building upon this foundation, we will construct an AI-driven prediabetes intervention management platform with intelligent decision support. This platform will generate personalized intervention strategies based on risk stratification, providing scientific evidence and practical support for advancing diabetes prevention and enabling precision management.

The Effects of Nextida-GC and Whey Protein on Postprandial Glycemic and Insulinemic Responses When Given 30min Before, 10min Before or With a Standardized Breakfast Test-meal in Healthy Adults With and Without Prediabetes

The goals of this clinical trial are to learn if Nextida-GC (a peptide derived from collagen) will reduce postprandial glucose responses when taken 30 minutes before, 10 minutes before or with the first bite of a breakfast test-meal consisting or bread, margarine and jam with a drink coffee, tea or water (each subject will choose a drink and have the same drink each time). The main questions it aims to answer are: Does Nextida-GC reduce glucose responses more than whey protein? What are the effects of Nextida-GC and whey protein on plasma glucose and serum insulin responses when given 30 minutes before eating, 10 minutes before eating, or with the breakfast test meal? Overall, is it better to take Nextida-GC 30 minutes before eating, 10 minutes before eating, or with the breakfast test meal? Participants will: Come to the research center (INQUIS Clinical Research, Toronto, Ontario, Canada) on 8 separate occasions (with bewteen 3 and 14 days between visits) after an overnight fast of at least 10 hours. Each participant will undergo all 8 treatments (one treatment per visit): Block 1 * 10 grams Nextida-GC in water 30 minutes before eating the test-meal * 10 grams Nextida-GC in water 10 minutes before eating the test-meal * water 30min before eating and 10g Nextida-GC in water with the test-meal * water 30min before eating, and water with the test-meal Block 2 * 10 grams whey protein in water 30 minutes before eating the test-meal * 10 grams whey protein in water 10 minutes before eating the test-meal * water 30min before eating and 10g whey protein in water with the test-meal * water 30min before eating, and water with the test-meal The order of the blocks will be randomized and the order of the treatments within the blocks will be randomized. On each occasions finger-stick blood samples for measuring glucose and insulin will be obtained 30, 10 and 0 minutes before starting to eat the test-meal and 15, 30, 45, 60, 90, 120 and 180 minutes after the first bite of the test-meal. The main outcome of the study is the area under the curve of plasma glucose from 0 to 180 minutes.

Mediterranean Diet and Blood Sugar Study

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.