Clinical Research Directory

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.

Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents

Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - \<15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c \< 10.0%. Sample Size: 30 subjects Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use Major Efficacy Outcomes: * Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight. * Secondary: time spent in hypoglycemia (\<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (\>180 mg/dl, 10.0 mmol/L) overnight. Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis

Maltodextrin Versus Sugar Water Carbohydrate Loading and Gastric Volume in Geriatric Lower Limb Orthopedic Surgery

Before surgery, patients are asked to fast so the stomach is empty and stomach contents cannot enter the lungs during anesthesia. Long fasting is uncomfortable and can raise blood sugar and stress responses in older adults. Giving a carbohydrate drink up to 2 hours before surgery is part of enhanced recovery (ERAS) programs. It is not clear whether a maltodextrin drink or sugar water leaves less fluid in the stomach of older patients. This randomized, double-blind study enrolls patients aged 60 years and older who are having elective lower limb orthopedic surgery under spinal or epidural anesthesia at Prof. Ngoerah General Hospital in Denpasar, Indonesia. Participants are assigned by chance to drink 400 mL of either a maltodextrin carbohydrate drink or sugar water 2 hours before anesthesia. The amount of fluid in the stomach is measured with bedside ultrasound before the drink and 2 hours after it. Blood glucose is measured before the drink, 2 hours after it and 6 hours after surgery. The neutrophil-lymphocyte ratio, a blood marker of inflammatory stress, is compared before surgery and 6 hours after surgery. The results are intended to show which drink is better suited to older surgical patients and to support safer and more comfortable fasting practice.

HealthMatters@24/7 eLearning for People Supporting Adults With Intellectual and Developmental Disabilities

The barriers faced by people with intellectual and developmental disabilities (IDD) begin in their mid to late 20s and often mirror the experiences of older adults (50+) living in the U.S. While evidence for successful population-specific health promotion programs and training, such as the 12-Week HealthMatters Program has been documented, an urgent need exists for continuous, readily available, on-demand training in these programs. Online training can substantially aid the widespread translation of evidence-based programs into practice and policy. This proposal seeks to test the effectiveness of an enhanced mode of translating the HealthMatters program into practice through the use of an on-demand e-Learning platform (HealthMatters@24/7) for staff in community based organizations (CBOs) in one state; thereby advancing the science of translational research. HO1. More CBOs in the asynchronous training program will have developed Strategic Action Plans for Health and Wellness, established Wellness Committees, and have equal or more resources and improved culture for health promotion at 1 year compared to CBOs participating in the current live HealthMatters TtT Workshop webinar. HO2. Staff in the asynchronous training group will have improved levels of learner/instructor satisfaction (job productivity, job performance, job satisfaction, organizational commitment, convenience) toward the training immediately after completing the enhanced mode of training, HM@24/7 compared to staff trained using the current live HealthMatters TtT Workshop webinar.

Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet

Rationale: Pasireotide is a second line medical treatment for acromegaly that can add value for patients with insufficient control of disease on 1st generation SRL, or 1st generation SRL + pegvisomant. A well-known advserse effect of pasireotide is development of hyperglycemia in 50-70% of cases. Eucaloric very-low carbohydrate ketogenic diet (VLCKD) improves hemoglobin a1c (HbA1c) and fasting plasma glucose (FPG) levels and can show even a long-term effect on glucose regulation in patients with acromegaly. Moreover, the eucaloric VLCKD has improved disease control in patients with acromegaly. Objective: The primary objective of this study is to evaluate the change in HbA1c from start of intervention (baseline of the core study) to post-four months of ketogenic diet compared to standard of care (core study) in patients developing pasireotide-induced hyperglycemia.The secondary objectives are to evaluate: * Differences between eucaloric very-low carbohydrate ketogenic diet and standard of care (diabetes medication) regarding: * Proportion of patients with target HbA1c (\<48mmol/L / \<6.5%) achieved without glucose lowering drugs (beyond metformine monotherapy) in both arms * Evaluation and sustainability of glycaemic control (HbA1c) and (dosage of) anti-diabetic drugs need to reach control * Biochemical control, and symptom score of acromegaly * Quality of life * Proportion of patients on 40 and 60 mg, proportion with normal IGF-1, tolerability, and safety of pasireotide * Exploratory evaluation of all eligible subjects considered for and started with pasireotide treatment to get a better insight into these complicated acromegaly patients and their metabolic profile. * Exploratory evaluation of other timepoints (start of pasireotide) to analyse course of Hba1c development from start of pasireotide until the end of the core study Study design: Study type: multicenter combined observational and interventional randomized controlled study. Allocation: randomized (1:1 ratio). Intervention model: parallel assignment. Masking: non (open-label). Primary purpose: supportive care. Study population: Adult patients with a confirmed diagnosis of acromegaly (for whom surgery is not an option, or for whom surgery has failed) and with inadequately GH and/or IGF-1 control (\>0.8xULN) or active disease symptoms with first-generation SRL, or with inadequately GH and/or IGF-1 control (\>0.8xULN) or active disease symptoms on second-line medical treatments for acromegaly (pegvisomant monotherapy or combination therapy with first-generation SRL and pegvisomant or dopamine agonist, respectively) and with a baseline Hba1c \<44 mmol/L (6.2%) - including those pre-treated with metformin in case of HbA1c ≥44 mmol/L (6.2%) and ≤64 mmol/L (8.0%) - in whom pasireotide is considered in the clinical setting. Intervention (if applicable): We aim to include 30 acromegaly patients with pasireotide-induced hyperglycaemia, to ensure that 20 patients complete the 4-month intervention. Subjects will be randomized 1:1 to open-label eucaloric very-low carbohydrate ketogenic diet (\<40 g of carbohydrate) or standard of care (i.e. metformin, followed by sitagliptin (DPP4-inhibitor), incretin-based therapy with liraglutide (GLP-1 receptor agonist), and insulin) at the time hyperglycemia is present. The randomized intervention period is 4 months (core phase of the study). Randomized subjects who reach the end of the randomized phase can continue with the open-label extension, and opt to continue their randomized diet or DM drug treatment or freely choose the other alternative for another 4 months (extension study). Main study parameters/endpoints: Evaluation of effect of treatment with eucaloric very-low carbohydrate ketogenic diet or diabetes medication on glycaemic control of pasireotide: \- Change in HbA1c from start core study to the end of the intervention (ketogenic diet vs standard of care) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants will have 8 visits to the outpatient clinic over a period of 12-15 months. This comes down to 480 minutes in total. During these visits, physical exam/anthropometric measurements will be performed and 2 blood tubes of 2,5 cc will be collected and 3 QoL questionnaires and one food diary will be filled out (total visit: 60 minutes). The usual burden for a single patient is 3-outpatient visits over a period of 1 year, which takes about 60 minutes in total and with the same volume of blood per visit.

Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are: * Does using the app help with short-term glycemic control? * Does using the app help with longer-term glycemic control? * Does using the app help increase physical activity? Participants will: * Wear a continuous glucose monitoring device for 6 months * Wear a physical activity tracker for 6 months * Use the study smartphone app for 6 months * Complete 3 in-person study visits with fasting blood draws * Report dietary intake intermittently throughout the study

Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.

Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM). The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment. The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.

Prognostic Value of Stress Hyperglycemia Ratio in Critically Ill Patients

Critically ill patients admitted to intensive care units (ICUs) frequently develop elevated blood sugar levels (hyperglycemia) as a result of acute illness-related stress, even if they do not have diabetes. While high blood glucose in the ICU is known to be associated with complications such as acute kidney injury and increased mortality, absolute glucose measurements alone may not distinguish acute stress from pre-existing chronic elevation. The Stress Hyperglycemia Ratio (SHR) evaluates the relative increase in blood glucose by dividing admission plasma glucose by the patient's estimated background average glucose derived from glycated hemoglobin (HbA1c). This measurement reflects the intensity of acute physiologic stress adjusted for baseline glycemic control. The purpose of this prospective observational study is to evaluate the prognostic utility of admission Stress Hyperglycemia Ratio in adult critically ill patients admitted to the intensive care units of Assiut University Hospitals. The study aims to determine whether admission SHR can predict in-hospital ICU mortality, acute kidney injury (AKI), the severity of acute organ failure measured by Sequential Organ Failure Assessment (SOFA) scores, the requirement and duration of invasive mechanical ventilation and vasopressor support, and the overall length of ICU stay. All participants will receive standard clinical care in accordance with institutional ICU protocols; no experimental drugs or clinical interventions will be administered as part of this study.

Early Glucose States and 72-Hour Care-Metabolic Clusters in Critically Ill Patients

Blood glucose patterns during critical illness may change together with treatment, nutritional support, organ support, and the frequency of glucose monitoring. This retrospective observational study examines the relationship between glucose patterns identified during the first 24 hours of ICU care and broader care-metabolic patterns identified during the first 72 hours. The study evaluates how these early and later patterns relate to each other and whether the 72-hour clusters are associated with subsequent ICU mortality. The early glucose-state definition is also examined in MIMIC-IV as an external supportive analysis. No treatment or clinical intervention is assigned by the investigators.

Studies of Blood Glucose and the Microbiome in Tumors and Cysts of the Pancreas

This prospective, single-center observational study investigates whether continuous glucose monitoring (CGM, 14 days) and gut microbiota composition (from a fecal sample) reveal patterns specific to pancreatic cancer, aiming to contribute to earlier detection and better assessment of disease severity. Adult patients under investigation, follow-up, or treatment for benign or malignant pancreatic/periampullary conditions are invited to participate in either or both parts of the study.

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

This study will investigate the prevalence of hyperglycemia (high blood sugar) in approximately 50 participants with pancreatic cancer. Sugar levels will be monitored with blood draws prior to each cycle of anti-cancer treatment until treatment ends or the participant's cancer worsens. Participants may receive any first-line systemic therapy for pancreatic cancer, including treatments given as part of another clinical trial. If treatment is needed to manage blood sugar levels, the treatment will be given according to the standard of care. All participants will be enrolled into the same group.

Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence

Inavolisib is an effective targeted therapy for certain patients with breast cancer, but it may cause high blood sugar (hyperglycemia) as a side effect. This multicenter, real-world study aims to evaluate whether implementing a risk-stratified management strategy for inavolisib-related hyperglycemia can positively impact patients' adherence to their treatment. By categorizing patients based on their blood sugar risk levels and applying corresponding management plans, researchers hope to improve medication compliance and overall clinical outcomes in real-world clinical practice.

Early Detection Initiative for Pancreatic Cancer

The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.

Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance \[Ra\]), primarily muscle glucose utilization (glucose rate of disappearance \[Rd\]), and adipose tissue related free fatty acid production (glycerol rate of appearance \[Ra\]). We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity. Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men. We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.

Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor

The aim of the study is to investigate the effects of coenzyme Q10 supplementation (150 mg twice daily; 300 mg/day for 12 weeks) on coenzyme Q10 status, glucose parameters, BDNF, myokines, and cognitive function in patients with mild cognitive impairment (MCI) or Alzheimer's disease (AD) and hyperglycemia, either without sarcopenia risk or with pre-sarcopenia/sarcopenia risk.

Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial

The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits.

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)

The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit. The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.

CGM-Based Glycemic Analysis After ESI

The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes. The main questions it aims to answer are: Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups? Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device. Participants will: * Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously * Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3 * Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection

Effect of Zinc on Glucose Homeostasis

The purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo. Specific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \[mg\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.

Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia

The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds (VOCs) in exhaled breath.

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are: * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass? Participants will be asked to: * Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks * Attend a prerandomization clinic prior to study * Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study * Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study * Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls. Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients

Poor glycemic control is common in critically ill patients with sepsis and is associated with increased morbidity and mortality; however, achieving safe and effective glucose management in the ICU remains challenging with conventional intermittent monitoring. Continuous glucose monitoring (CGM) offers real-time interstitial glucose readings and has the potential to improve detection of dysglycemic events, enhance adherence to glycemic protocols, and reduce nursing workload. This prospective, randomized controlled trial was designed to evaluate the accuracy, clinical effectiveness, and operational utility of a factory-calibrated CGM system (FreeStyle Libre II) compared with standard blood glucose monitoring (fingerstick, arterial, and venous measurements) in septic ICU patients. The primary outcomes include CGM accuracy against reference methods, protocol adherence rates, time efficiency, and the incidence of hypoglycemic and hyperglycemic events. The findings of this trial will help determine whether CGM can provide a reliable, clinically feasible, and time-saving alternative for glycemic management in this high-risk population, thereby supporting its integration into routine ICU practice and informing future larger-scale studies on long-term outcomes and cost-effectiveness.