Clinical Research Directory

Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes

Pregnant women aged 18-45 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.

Food Orders on Blood Glucose and Fuel Use at Rest

Consuming a carbohydrate-rich food as the final food in a meal, as compared to the first food in a meal, has been shown to reduce blood glucose levels after eating in both diabetes patients and in healthy controls. However, gaps remain in the literature in this area of research, and currently little is known about how substrate (fuel) use is impacted by altering food order. In addition, most studies to date have used a mix of meat and plant foods, while little research has focused exclusively on vegetarian foods. This randomized experiment will examine how altering the order of foods eaten in a vegetarian meal impacts blood glucose and fuel utilization at rest.

Day and Night Closed-loop in Young People With Type 1 Diabetes

The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group). It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy. Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

Group Education Trial to Improve Transition for Parents of Adolescents With T1D

The investigators will study if group education for parents of adolescents with type 1 diabetes (T1D) will improve the transition from adolescence to adulthood. The investigators aim to conduct a pilot randomized controlled trial (RCT) of parent group education sessions to assess the feasibility and refine the intervention to inform a full-scale multicenter RCT. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. The aims for the future full-scale multicenter RCT are to assess the effect of parent group education sessions integrated into pediatric care, compared with usual care on self-management, hemoglobin A1c (HbA1c), adverse outcomes and validated measures during the transition from adolescence to adulthood. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment.

The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response

The subject of doctoral dissertation: Assessment of the effects of a meatless, ketogenic restrictive diet on body composition, strength capacity, oxidative stress and immune response During planning of research and topic of the doctoral dissertation, it was considered how to modify a standard ketogenic diet rich in saturated fatty acids so that the use of this model of nutrition has the most anti-inflammatory effect. Therefore, it was decided to conduct a research to check whether a diet rich in omega-3 polyunsaturated fatty acids will show such an effect when following a high-fat diet. Hypotheses: 1\. The ketogenic diet reduces systemic inflammation. 2.The ketogenic diet reduces oxidative stress. 3. The ketogenic diet reduces body fat. 4. A ketogenic diet does not worsen strength performance.

METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)

The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center/Diabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.

Effect of NMN Supplementation on Organ System Biology

The goal of this proposal is to determine whether the beneficial effects of NMN on metabolic function observed in rodents applies to people.

Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy

Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test: Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure. The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT. Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes. The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT. Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis.

Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years: 1. Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Using the continous glucose monitoring (CGM) sensor and an exercise tracker will promote self-motivation and awareness by positive reinforcement and behavioural changes to improve diet, control body weight and increase physical activity in this group of post-partum women who are at high risk for developing Type II Diabetes. 2. The use of the continous glycose monitoring (CGM) sensor and exercise tracker will motivate women to modify their dietary food intake and physical activity over time, reducing their cardiovascular risk factors for developing metabolic syndrome by lowering their baseline blood pressure, BMI, reducing their waist circumference and body fat mass, glycaemic levels and fasting lipids within the targeted healthy range. 3. There will be an increase in the quality adjusted life years (QALYs) gained based on improvements in HbA1C and other proximal outcomes at the end of the trial.

Intestinal Metabolic Reprogramming as a Key Mechanism of Gastric Bypass in Humans

The purpose of this research study is to determine how gastric bypass surgery effects metabolism in obesity and Type 2 Diabetes. One mechanism that has been investigated in animal models is change to the biology of the small intestine (Roux limb) and how glucose and other fuels are metabolized (or how the body digests and uses sugar and other fuels). This study will evaluate the role of the intestine in the beneficial metabolic effects of gastric bypass surgery. It specifically will examine whether the intestine increases its metabolism and its activity, and whether this results in an increase in fuel utilization. Thirty two (32) subjects will be recruited (18 with and 14 without Type 2 Diabetes). At the time of gastric bypass surgery, a small piece of intestine that is usually discarded will be collected. At three time points over the first year after surgery, intestinal samples will be obtained by endoscopy or insertion of a lighted flexible tube through the mouth. Blood samples will be taken at all time points, as well. All samples will undergo comprehensive metabolic analyses. Comparisons will be made between the two groups to understand the metabolic changes over time and if there are differences between the two groups.

Brain Metabolism Observed at 3 Tesla or 7 Tesla in Health and Metabolic Disease

The goal is to develop methodology to monitor flux in the citric acid cycle in brain via 13C nuclear magnetic resonance (NMR) spectroscopy at 7 Tesla or 3 Tesla.

Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease

Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Right now, there is no approved medication for this condition-only a careful diet reduced in sugars and refined carbohydrates can sometimes help reduce symptoms. The AnPHy-ReD study is a personalized research study, designed for just one patient. This patient is a 52-year-old man who has been struggling with severe post-meal low blood sugar ever since his stomach was removed due to tumor in 2017. He also has end-stage kidney disease and needs dialysis three times a week. The study is being conducted at the Cantonal Hospital of Olten in Switzerland and lasts 10 weeks, including 24 study visits. Most of these visits will happen during the patient's regular dialysis sessions. For 6 weeks, the patient will take either the drug Anakinra or a placebo (a substance with no active ingredient), in a randomly chosen order. Neither the patient nor the doctors will know which one he is taking at any given time. During the study, the medical team will perform various tests, including physical check-ups and blood samples to look at sugar levels, various hormone levels and inflammation in the body. The patient will also wear a continuous glucose monitor (CGM) to track his blood sugar levels 24/7. In addition, he will do several mixed meal tests-this means drinking a shake containing fats, proteins, and sugars during a study appointment to see in real time how his body processes food, with doctors measuring changes in blood sugar, hormone and inflammation markers over time. During the study duration any side effects or symptoms will be closely monitored. At the end of the study, the team will compare the results between the times the patient took Anakinra and the times he took the placebo. This will help find out if Anakinra can reduce sharp drops in blood sugar after meals and improve his overall condition.

Study of Fat Tissue's Ability to Take up Sugar in the Obese Population

People who are obese often have insulin resistance (inability of insulin to properly control blood sugar) and high blood sugar. However, not all people with obesity have this problem. About one-third of people with obesity have normal sugar metabolism (the way your body uses sugar). Similarly, not all people who are lean are also metabolically healthy and a subset of people who are lean are referred to as metabolically abnormal lean (MAL) or metabolically obese lean because they have the abnormalities in glucose metabolism typically associated with obesity. The reasons why some people with obesity have a problem with blood sugar control and others do not are not entirely clear. It is thought that impaired muscle sugar uptake is the main problem related to high blood sugar in people with obesity. However, adipose tissue (fat tissue) also consumes a substantial amount of blood sugar. Therefore, it is unclear whether muscle or adipose tissue (fat tissue) are primarily responsible for altered blood sugar concentrations in persons with metabolically abnormal obesity (MAO) (those with insulin resistance), compared to those with metabolically normal (healthy) obesity (MNO), or whether "healthy" adipose tissue (fat tissue) expansion in MNO people compared with lean people provides a vessel for blood sugar removal that helps maintain normal blood sugar concentration. Accordingly, the investigators will determine the amount of sugar that is taken up by the body and in the cells of adipose tissue (fat tissue) and muscle by infusing labeled sugar into the blood and looking at its disappearance from blood and appearance in adipose tissue (fat tissue) and muscle. The investigators will also determine how well insulin, a hormone that controls blood sugar, turns on signals that stimulate sugar uptake in fat and muscle cells. These studies will be done after an overnight fast and during an infusion of sugar and insulin (hyperinsulinemic-euglycemic clamp), in sex- and age-matched people who are insulin resistant and insulin sensitive. People with obesity will also be invited to complete a \~10% diet-induced weight loss program and will be studied again after they have achieved the weight loss goal. A group of sex- and age-matched metabolically normal lean participants will serve as control group. An attempt will be made to also study a group of sex- and age-matched metabolically abnormal lean participants.

Obstructive Sleep Apnea and Glucose Metabolism

Many adults who are overweight have obstructive sleep apnea (OSA) which disrupts sleep and makes it difficult to breath during the night. OSA increases the risk for a person to become insulin resistant and diabetic. It is not known why OSA causes this problem, i.e., whether it is disrupted sleep or lack of oxygen., which can change how the body handles glucose in adipose tissue, muscle tissue and liver. The purpose of this research study is to determine the key issues and mechanisms responsible for dysregulated glucose metabolism in people with OSA. The investigators will do this by comparing glucose metabolism in people who have OSA, and those who do not, and by evaluating the effect of treating OSA by providing continuous positive airway pressure (CPAP) or simply oxygen during the night. The proposed study will evaluate the primary causes(s) (hypoxia, sleep fragmentation, or both) and pathophysiological mechanisms responsible for the OSA-associated metabolic abnormalities. Knowing the primary cause of Obstructive Sleep Apnea and pathophysiological mechanisms responsible for the OSA-associated metabolic abnormalities could help develop potentially novel therapeutic strategies to provide treatment for adults in improving OSA and associated comorbidities.

Animal and Plant Proteins and Glucose Metabolism

The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.

Specificities of Atypical Non AutoImmune Diabetes (ANAID) in the French West Indies

Genetics variants could be involved in atypical non-autoimmune diabetes revealed by ketoacidosis. The objective of this research will be to determine the relationships between the genetic variants already described in known monogenic diabetes or identified as involved in glucose metabolism and its regulation, in insulin signaling pathways or in insulin secretion itself in subjects of African and Indian ancestry with atypical forms of non autoimmune diabetes.

An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D

This is an open-label, multicenter, Phase 1 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D

Regulation of Endogenous Glucose Production by Central KATP Channels

Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.

Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes

The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.

Relative Contribution of Brain Insulin Action for Postprandial Metabolism

The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women. Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

The CGM-OGTT Glycemic Homeostasis Study

This is a prospective, exploratory, observational study aimed at investigating the mechanisms of glycemic homeostasis by comparing continuous glucose monitoring (CGM) data with results from the oral glucose tolerance test (OGTT). The study plans to enroll approximately 225 participants aged 18-70 years who are at risk for or suspected of having glucose metabolism disorders, but without a prior diagnosis of diabetes. Participants will be equipped with a blinded CGM device for 10-14 days. During this period, they will perform two standardized mixed-meal tolerance tests (MMTT) at home. Subsequently, they will undergo a standard 75g OGTT at the hospital, where blood samples will be collected at multiple time points to measure glucose, insulin, C-peptide, and gastrointestinal hormones (GLP-1, GIP). Based on the 2-hour blood glucose value from the OGTT, participants will be naturally categorized into three groups for comparative analysis: Normal Glucose Tolerance (NGT), Pre-diabetes (Pre-DM), and Newly Diagnosed Type 2 Diabetes (T2DM). The primary objective is to establish a quantitative relationship between CGM-derived parameters (e.g., glycemic variability, time-in-range) after the MMTT and the OGTT diagnostic results. Secondary objectives include assessing the feasibility and correlation between home-based MMTT and standard OGTT, exploring the impact of gastrointestinal hormone responses on daily glucose fluctuations, and investigating the association between postprandial glucose dynamics and vascular reactivity (e.g., postprandial hypotension).

Rare and Atypical Diabetes Network

RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.

Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring

Gestational diabetes is one of the most common medical disorders in pregnancy and is a major risk factor for the postpartum development of dysglycemia. Despite the high risk of developing dysglycemia, 50-80% of women with gestational diabetes are not receiving testing within a year postpartum. The investigators will conduct a prospective cohort study to examine the use of continuous glucose monitoring immediately postpartum to estimate the risk of maternal dysglycemia postpartum.