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309 active trials for Diabetes Mellitus

Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

The purpose of this study is to assess the effects of diabetes mellitus (DM) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (FLACS). Patients with DM routinely undergo FLACS, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. Importantly, DM alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. The results from this study will provide insight into the risks and benefits of FLACS in patients with DM.

Start: May 2021

A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users

The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.

Start: March 2020

Development and Validation of DM and Pre-DM Risk Prediction Model

Many DM and pre-DM remain undiagnosed. The aim is to develop and validate a risk prediction function to detect DM and pre-DM in Chinese adults aged 18-84 in primary care (PC). The objectives are to: Develop a risk prediction function using non-laboratory parameters to predict DM and pre-DM from the data of the HK Population Health Survey 2014/2015 Develop a risk scoring algorithm and determine the cut-off score Validate the risk prediction function and determine its sensitivity in predicting DM and pre-DM in PC Hypothesis to be tested: The prediction function developed from the Population Health Survey (PHS) 2014/2015 is valid and sensitive in PC. Design and subjects: We will develop a risk prediction function for DM and pre-DM using data of 1,857 subjects from the PHS 2014/2015. We will recruit 1014 Chinese adults aged 18-84 from PC clinics to validate the risk prediction function. Each subject will complete an assessment on the relevant risk factors and have a blood test on OGTT and HbA1c on recruitment and at 12 months. Main outcome measures: The area under the Receiver operating characteristic (ROC) curve, sensitivity and specificity of the prediction function. Data analysis and expected results: Machine learning and Logistic regressions will be used to develop the best model. ROC curve will be used to determine the cut-off score. Sensitivity and specificity will be determined by descriptive statistics. A new HK Chinese general population specific risk prediction function will enable early case finding and intervention to prevent DM and DM complications in PC.

Start: April 2020

Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients

Current data estimated that 451 million people, (age 18-99 years) suffered from diabetes world wide in 2017, and are expected to rise to 693 million by 2045. Among them, type 2 diabetes mellitus (T2DM) accounts for around 90% of all cases with diabetes. T2DM is associated with several deterimental microvascular and macrovascular complications (Annani-Akollor ME et al ., 2019) . As such, effective management of the disease is crucial. The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommend metformin as the first therapeutic choice for T2DM management with concurrent lifestyle modifications. Reports indicated that metformin improves peripheral insulin sensitivity and reduces the risk of cardiovascular mortality in T2DM in addition to its beneficial effects on weight loss and vascular protection. Nonetheless, as with most medications, metformin has some side effects. Though most of these side effects are mild, reports indicated that metformin use is associated with diminution of vitamin B12 level . Also, advanced age of patients with T2DM, nutritional deficiency, and malabsorption are other contributing factors for its deficiency . The proposed mechanisms for deficiency include, impairment of calcium dependent absorption from the gut, alteration in small bowel motility resulting in bacterial overgrowth, and a reduction in intrinsic factor levels . Metformin-induced vitamin B12 deficiency has also been associated with neuropathy. The neuropathy associated with vitamin B12 deficiency ranges from paresthesia and attenuated peripheral sensation in response to changes in mental status and proprioception which overlap with diabetic neuropathy. The progression of vitamin B12 deficiency-induced neurologic damage can, however, be abated through early detection and vitamin B12 therapy. Nonetheless, if peripheral neuropathy due to deficiency of vitamin B12 is misconstrued as diabetic peripheral neuropathy , permanent neurological damage may occur. Several studies have investigated the individual effects of the dose and duration of metformin therapy on vitamin B12 levels .The reported results are inconsistent, with some studies reporting an association with the dose but not the duration and other studies reporting an association only for the duration. however, A few studies did not find an association with either the dose or the duration.. This could be attributed to the fact that, in any given patient with T2DM, vitamin B12 levels could be influenced predominantly by either the dose or the duration of metformin therapy. Hence, it is important to involve both the dose and duration of metformin therapy into the assessment of vitamin B12 deficiency. Micronutrient deficiencies constitute a global health issue, particularly among countries in the Middle East .The World Health Organization (WHO) has divided this region into overlapping country clusters with regard to nutrition stages and dominant nutrition problems, including major risk factors and underlying causes, program interventions, and gaps in response to these problems. Countries in early nutrition transition (e.g., Egypt, Jordan, Lebanon, Morocco, and Palestine) are typically characterized by a moderate prevalence of overweight and obesity, moderate levels of undernutrition in specific population groups, and widespread micronutrient deficiencies/inadequacies. Metformin Usage Index is the product of the dose of metformin (mg) used and its duration divided by 1000. An index which incorporates both of these factors would not only be useful to understand the cumulative impact on vitamin B12 levels but also provide an objective threshold for initiating vitamin B12 supplementation . So , we aimed to assess the relationship between the dose and duration of metformin therapy with vitamin B12 levels using the "Metformin Usage Index" (MUI) in Egyptian type 2 diabetic patients where the incidence of nutritional deficiencies are not uncommom in order to formulate their appropriate management strategies . The aim of our study is to evaluate the combined effect of both dose and duration of metformin therapy on vitamin B12 levels in Egyptian patients with type 2 diabetes mellitus (T2D).

Start: May 2021

The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes

The objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the COVID 19 (time 1 - T1), after 1 year (time 2 - T2) and 2 years (time 3 - T3) duration. In patients with all types of diabetes, the investigators will compare the value of blood pressure, LDL cholesterol, BMI (body mass index) and glycated haemoglobin in T1, T2 and T3 during outpatient control.

Start: April 2021

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.

Start: May 2021

Fostering Sustainability Through Diabetes Self-Management Support

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Start: March 2016

Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function

Background: - Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease. Objectives: - To compare two forms of diet and their effects on insulin resistance and the brain. Eligibility: - Women ages 55 70 with insulin resistance. Design: This study requires 6 clinic visits over 9 12 weeks. Participants must fast before visits. Visit 1, screening: Medical history, physical exam, and blood and urine tests. Participants will get a wrist device to wear for 4 days. Visit 2: Weight and waist measurement. Blood drawn. Questionnaires and thinking tests. Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back will remove <TAB>fluid. Participants will drink a nutrition shake. Blood will be taken 12 times over 4 <TAB>hours through a thin tube in <TAB>the arm. Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. <TAB>They will have a coil on their head and may do tasks. Participants will get advice about healthy eating and be randomly put in one of 2 groups. One group will get <TAB>nutrition shakes to drink. Visits 3 5: Weight and waist measurements, vital signs, blood draw, and questionnaires. Between visits, participants will get a call or email to check how they are doing. Visit 6: Repeat of visit 1. Participants will wear the wrist device for 4 more days, have a follow-up contact, then the study is finished.

Start: June 2015

Individualized, Technological Interventions for Diabetes Care in the COVID-19 Ward

During the current Covid-19 pandemic, many hospitals worldwide have been overwhelmed and strategies based on new technologies have been considered to improve the outcomes in patients with diabetes and Covid-19 and to prevent healthcare workers' exposure. Point-of-care blood glucose measurements, with the need of frequent and intermittent blood glucose testing and the associated time burden for hospital staff workers, have evident limitations. To this respect, continuous glucose monitoring (CGM) might represent an effective tool in hospitalized patients. The latest CGM devices have alarms alerting clinicians (or patients) to abnormal blood glucose values. Furthermore, CGMs not requiring calibration with capillary glucose testing have the potential to decrease both nurse and patient burden. Insulin therapy is recommended in hospitalized patients with diabetes and Covid-19, conventionally by multiple daily insulin injections, i.e., rapid-acting insulin before meals and long-acting insulin once-a-day. Such a complex regimen demands also multiple daily fingerstick for glucose control. Use of continuous subcutaneous insulin infusion in hospital has been considered, and simple, less sophisticated pumps might be appro¬priate for prompt use by healthcare providers not specialized in diabetes treatment. V-Go® is a skin-patch insulin delivery device to be replaced every 24 h. It is fully mechanical, without tubing or electronics, and does not require any programming. It delivers a continuous basal infusion of rapid-acting insulin and allows for additional units before meals. Therefore, the implementation of CGM and automated insulin infusion in Covid-19 hospitals has the potential to improve clinical outcomes, protect frontline healthcare workers, and preserve personal protective equipment. However, because only observational retrospective data for CGM use and no data on insulin pump use are currently available, randomized controlled trials are needed to determine whether using these technologies in hospital is of significant help. The aims of this study are to explore, in patients with diabetes in COVID-19 wards, whether using continuous glucose monitoring with a glucose telemetry system and/or using a disposable insulin pump may improve blood glucose control and Covid-19 outcomes, and facilitate diabetes management.

Start: March 2021

The Effect of COVID-19 on Diabetes Mellitus

The study aimed to evaluate the effect of SARS-COV-2 infection on metabolic status in patients with diabetes mellitus. Patients' HbA1c levels before and after SARS-COV-2 infection will be evaluated.

Start: March 2020

The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study. The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Start: March 2020

Saxenda in Obesity Services (STRIVE Study)

A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.

Start: November 2017

1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin Ratio as a Potential Biomarker for Islet ?-cell Function and Insulin Resistance Among Patients With Type 2 Diabetes Mellitus

Hyperglycemia is a major risk factor for the micro- and macro-vascular complications of diabetes . Lowering blood glucose levels has been shown to reduce the incidence of diabetes complications. Therefore, there is a need for a simple surrogate biochemical marker for glycemic variability. Glycated hemoglobin (HbA1c) is the standard clinical measurement used to monitor glycemic status and is recommended to assess control of diabetes over the preceding 2-3 months. However, being a measure of mean glucose, it does not reflect glucose variability. It is well known that insulin secretion defects of islet ? cells and/or tissue insensitivity to insulin are common pathophysiological mechanisms of diabetes mellitus (DM) . The elevation in the blood glucose level usually represents the degree of glucose metabolism disorder, which is generally assessed by glycated hemoglobin A1c ( HbA1c) and indirectly reflects the extent of ?-cell function damage . In the recent years, 1,5-anhydroglucitol (1,5-AG) has received attention as a short-term blood glucose index that reflects the average blood glucose level 1,5 AG reflects the average maximum blood glucose level during the past 1-2 weeks and is reported to be a more sensitive marker of glucose variability and postprandial hyperglycemia than HbA1c, even for patients with prediabetes and for those with well or moderately controlled diabetes . (1,5 AG ) is structurally similar to glucose . Due to this similarity, glucose inhibits renal reabsorption of 1,5 AG by competitive inhibition ,resulting in an inverse correlation of 1,5 AG with hyperglycemia . 1,5-AG levels are acting as an effective supplement to HbA1c. Additionally, previous study showed that 1,5-AG and HbA1c had opposite curves with increasing blood glucose levels; specifically, with the increase in HbA1c levels, 1,5-AG levels decreased significantly . Therefore, we speculate a ratio of 1,5- AG / HB A1C in relation to islet ?-cell function and insulin resistance. The aim of our study was to evaluate the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet ?-cell function and insulin resistance among patients with type 2 diabetes .

Start: May 2021

Stem Cell Therapy for Chronic Kidney Disease

The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.

Start: May 2021

Asian Diabetes Outcomes Prevention Trial

The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.

Start: July 2019

Implementation of ABI and WIfI in Rural Health Clinics

The objective of this project is to assess the fidelity and sustainability of in improving provider performance with Ankle Brachial Index (ABI) assessment and ulcer staging with the would ischemia foot infection (WIfI) tool for new patients with lower extremity ulcers due to peripheral artery disease (PAD) and diabetes mellitus (DM) at RHCs in the telemedicine network through a rural provider education program that is aligned with preexisting continuing medical education activities.

Start: March 2020

Diabetes Risk Education and Communication Trial

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. This pilot study will develop and evaluate the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates information about diabetes risk and treatment options for preventing diabetes among primary care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project has large potential to impact public health by developing a scalable intervention to promote the use of evidence-based treatments that lower diabetes risk in this population.

Start: November 2017

Artificial Sweeteners in Breast Milk

This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.

Start: November 2020

Cohort Study on Patient Outcomes, Effectiveness and Cost-effectiveness of Intervention Programmes for DM/HT Patients

Objectives: To determine the outcome trajectories of patients with hypertension (HT) and/or diabetes mellitus (DM), and evaluate the long-term effectiveness and cost-effectiveness of the Risk Assessment and Management Programmes (RAMP) and other primary care services such as Patient Support Call Centre (PSCC) on reducing complications and mortality Design: Population-based cohort study Setting: Hospital Authority (HA) primary care clinics Participants: All patients aged ?18 years with DM or HT managed in HA primary care clinics between 2006 and 2021 Main outcome measures: (1) incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality); (2) service utilization (out-patient clinics, Accident and Emergency and overnight hospitalizations); (3) Incremental cost-effectiveness ratio per complications or all-cause death avoided, and per QALY gained by RAMP or PSCC. Methods: A naturalistic cohort study (maximum 10-year follow-up) and retrospective data extraction from the HA clinical management system (CMS) database will be conducted to identify and correlate outcome trajectories of HT and/or DM patients with personal, service delivery and process of care factors. Outcomes of propensity score matched cohorts who have and have not participated in the programmes will be compared. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression will be conducted to evaluate the effect of RAMP, PSCC and other primary care services on the risk of complications, mortality and service utilization. Empirical costs and effectiveness data will be used to calculate cost-effectiveness from the provider's perspective. Significance: Findings will inform how to optimize service delivery for HT/DM patients in Hong Kong

Start: August 2019

Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults? What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?

Start: January 2018