Clinical Research Directory

Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and reproductive health in patients with PCOS.

Effects of Habitual Water Intake on Thirst in Healthy Young Adults Explained by Osmoadaptive Metabolism, Brain and Kidney Function (Adapt-Thirst)

Social relevance: For 30 years, people have been confused about how much plain water to drink. Over 30 years, health professionals have criticized media advice to drink 8 glasses of water per day, citing lack of evidence (Valtin et al, 2002; Yamada et al, 2022). Health authorities have not set drinking water-specific recommendations, assuming 1) that any or all types of drinks hydrate equivalently, i.e. that people do not need to drink plain water to replace lost body water, and 2) the average healthy person can rely on thirst as guide for water intake. The lack of drinking water-specific recommendations significantly impacts daily lives because it translates into limited or no support for drinking water in public health services, laws, and retail options. Scientific relevance: Thirst is considered the primary driver of water intake and main defense against body water deficit in healthy young adults (IOM, 2005). Health authorities set total water intake recommendations for the average healthy man and woman (e.g. 2.5 L/d for men and 2.0 L/d for women in Europe) but, additionally, advise people to use thirst as a guide for water intake, recognizing that individual water requirements vary widely (EFSA, 2010; IOM, 2005). Although thirst can be satiated by water intake, it can also be ignored per custom (Greenleaf, 1992) or suppressed by an upward-shifted thirst threshold. The thirst threshold, the set-point where osmoreceptor cells shrink and release their neural or hormonal signal, is a function of the solute concentration or osmolality inside and outside the osmoreceptor cells (Nose et al, 1988a,b). Cells with higher intracellular solute content require a higher external osmolality to shrink. Specific Aims The ultimate goal of this study is to address gaps in the literature about drinking water and check assumptions that limit the development of drinking water-specific recommendations. The study will examine if osmoadaptation to chronic hypertonicity, due to daily intake of hypertonic fluid sources, can explain suppressed thirst in healthy individuals under conditions of daily life. To facilitate causal inference about drinking water effects for long-term health, this study was designed to link experimental data about osmoadaptation at the cellular level with clinical data relevant for conditions of daily life in Salzburg Austria with population-based data about water intake and chronic disease risk in Salzburg Austria. This study will test effects of drinking enough plain water to dilute urine everyday for 4 weeks (about 500 mL 4 times per day in summer). The study will include healthy, normal weight, young, men and women, who all usually meet European adequate intake recommendations for total water intake (TWI), but usually consume less than 1L/d PWI, and have biomarkers of chronic hypertonic stress (concentrated urine and saliva) for 4 consecutive weeks before starting the randomized study.

Meta-analyses of Soy Protein and Its Food Sources for Cholesterol Reduction

Although soy protein has approved health claims in Canada and the US, and is recognized by major cardiovascular clinical practice guidelines for the reduction of cholesterol and risk of coronary heart disease (CHD), these claims are based almost exclusively on evidence from foods containing isolated soy protein (ISP). The role of other non-ISP food sources of soy protein (e.g Tofu, tempeh, edamame) in these effects is unclear. The role of food form and matrix (e.g soy beverage versus meat analogue) on the effects of ISP is also unclear. As national dietary guidelines and clinical practice guidelines for nutrition therapy shift from a focus on single nutrients to a focus on foods and dietary patterns, it is important to understand whether non-ISP food sources of soy protein and ISP food sources with different food matrices produce the same reductions in LDL-cholesterol and CHD risk. To strengthen the evidence-base for health claims and guidelines development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of ISP and non-ISP food sources of soy protein on stablished lipid targets in individuals with and without dyslipidemia.

Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)

Investigators propose to study youth across the spectrum of body mass index (BMI) and dysglycemia. This approach will allow investigators to disentangle the relationship of key features of type 2 diabetes (T2D) risk (e.g. obesity) with intermediary physiologic changes (e.g. insulin resistance, inflammation, β-cell dysfunction and dysglycemia) that pose a risk for the brain. Investigators will determine which of these factors are most associated with differences in brain structure and function among groups, over time, and how these effects differ from normal neurodevelopment.

The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes.

The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients. The main question it aims to answer is: • Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes? Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge.

Effect of a Food Supplement on Blood Glucose Levels in Patients With Impaired Glucose Values

The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months

Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study

The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment. The main questions it aims to answer are: • Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment? Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.

Meta-Analyses of the Effect of Plant Protein Versus Animal Protein on Cardiometabolic Risk

Vegetarian diets have been associated with a reduced risk of preventable diseases such as type 2 diabetes and cardiovascular disease. These effects may be mediated through direct or indirect pathways. Although the high intakes of nuts, legumes, dietary fibre, whole grains, and unsaturated plant oils have each individually been associated with lower risk of type 2 diabetes and cardiovascular disease, so too has the displacement of red meats, processed meats, and saturated animal fats. One of the most important considerations in moving from animal-based diets to more plant-based diets is the replacement of animal proteins (e.g. meat, fish, dairy, eggs) with vegetable proteins (e.g. legumes, nuts, and seeds). It is unclear whether this particular replacement alone results in advantages for metabolic and cardiovascular health. To improve evidence-based guidance for dietary guidelines and health claims development, we propose to conduct a series of systematic reviews and meta-analyses of the effect of plant-based protein in exchange for animal protein on blood lipids, glycemic control, blood pressure, body weight, uric acid, markers of non-alcoholic fatty liver disease (NAFLD), and kidney function and injury. The systematic review process allows the combining of the results from many small studies in order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The investigators will be able to explore whether the effects of replacing animal-based protein for plant-based protein hold true across different sexes, age groups, and background disease states and whether the effect depends on the protein source, dose, or background diet. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing recommendations for the general public, as well as those at risk of heart disease and diabetes.

Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).

Polish Registry of Diabetes (PolReD)

The aim of this project is to create a registry of diabetic patients, containing a detailed clinical profile of each patient, along with omics data, which will be analyzed using artificial intelligence algorithms, and their results will be implemented in the form of new recommendations of care for high-risk patients and those already suffering from diabetes. The study will be conducted prospectively. The project participants will be patients with diabetes, patients at high risk of developing diabetes and a control group of normoglycemic patients who will participate in study visits at the Clinical Research Center of the Medical University of Bialystok.

The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.

Snus and Home Blood Pressure

Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake. 28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation, as well as after snus relapse if such a relapse occurs.