Al Kuwayt

Diabetes mellitus is a common and challenging condition in the Middle East, often linked with psychological issues like depression and anxiety. This study explores whether combining breath awareness with pyramid energy can improve mental health and glycemic control in people with type 2 diabetes mellitus (T2DM) who also have symptoms of depression and anxiety. Depression and anxiety are more frequent in people with diabetes, and the COVID-19 pandemic has worsened this burden. Mindfulness-based approaches like breath awareness and yoga have shown promise in reducing psychological distress, and the unique structure of a pyramid may enhance these effects. The study is a randomized controlled trial where eligible participants with T2DM and depression or anxiety symptoms are assigned either to an intervention group or a waitlisted control group. The intervention group receives 1 to 2 hours daily of breath awareness training using a pyramid head cap for six weeks, along with group discussions on healthy mindful living. The control group continues usual care but will receive the breath awareness training after the study ends. Both groups undergo assessments at baseline, week 6, and week 12. Participants will have blood tests measuring glycemic control and other biomarkers at three points and complete questionnaires on anxiety, depression, sleep quality, stress, and mindfulness. Researchers will monitor attendance to track how well participants follow the training. The main outcomes include changes in anxiety and depression scores after six weeks. The study lasts 12 weeks in total, with follow-up assessments to evaluate lasting effects.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare blood cancer recognized as a distinct disease since 2008. There is currently no agreed-upon best treatment for BPDCN, and because the disease is so uncommon, international collaboration is needed to collect detailed information on how BPDCN presents, is diagnosed, and responds to different treatments. The study aims to build a large global database of BPDCN patients, examine disease characteristics and outcomes across various treatments, identify factors that affect prognosis, and develop treatment recommendations based on collected data. This study is an international registry collecting both past and new patient data from multiple centers worldwide. Participating centers gather detailed patient information through questionnaires, including patient and disease characteristics, treatment details, outcomes, causes of death, and the timing of data collection. The registry does not involve any experimental treatments but focuses on collecting comprehensive clinical data to better understand BPDCN. Participants provide informed consent if enrolled prospectively, and data quality is managed by the Immune Oncology Research Institute. Researchers will analyze overall survival over five years as a key outcome. This registry supports ongoing monitoring and data collection to improve knowledge about BPDCN and guide future treatment strategies.

Researchers are investigating whether adding pioglitazone to the SGLT2 inhibitor dapagliflozin, alongside insulin therapy, can improve blood sugar control and reduce ketone levels in patients with type 1 diabetes (T1DM). This Phase 4 trial addresses challenges with current insulin treatment, such as weight gain and insulin resistance, and aims to enhance glucose lowering while minimizing risks like diabetic ketoacidosis (DKA). The study involves 120 patients with T1DM who are otherwise healthy. After screening and a 4-week run-in period, participants will receive dapagliflozin for 12 weeks. At week 16, they will be randomly assigned to receive either pioglitazone, starting at 15 mg and increased to the highest tolerated dose, or a placebo, for 16 weeks in a double-blind manner. Participants will undergo various tests including mixed meal tolerance tests, indirect calorimetry, and continuous glucose monitoring to assess glucose control and ketone levels. The main outcome measured is the decrease in HbA1c after 28 weeks. Researchers will monitor safety and metabolic effects throughout the study to understand if the combined treatment can better control blood sugar without increasing risks like ketoacidosis or hypoglycemia.

Falls are a serious risk for older adults, especially those who have undergone total knee replacement (TKR) due to osteoarthritis of the knee. This research evaluates whether adding a comprehensive fall prevention program to conventional physiotherapy can better reduce falls, improve balance, and enhance functional ability in elderly women after TKR. The study is a parallel group, randomized, single-blinded controlled trial lasting 24 weeks. Participants will be divided into groups where one group receives standard physiotherapy, which includes strengthening, knee range of motion exercises, and gait re-education, while the other group receives the same physiotherapy plus a guided fall prevention program based on the post-TKR protocol at Al-Razi Orthopedic Hospital. This integrated approach aims to address muscle weakness and balance issues that contribute to falls after surgery. During the 24-week study, researchers will monitor the number of falls at baseline, 12 weeks, and one year. They will also assess participants' balance and functional ability through various evaluations. The study focuses on elderly females aged 60 and above who had unilateral TKR due to primary osteoarthritis. Safety and long-term effects of the interventions will be closely observed throughout the trial period.

Metabolic dysfunction-associated steatotic liver disease (MASLD), previously called non-alcoholic fatty liver disease (NAFLD), is a common liver condition linked to obesity, diabetes, and cholesterol problems. It ranges from simple fat buildup in the liver to more severe states like metabolic dysfunction-associated steatohepatitis (MASH), liver fibrosis, cirrhosis, or liver cancer. Patients with MASH also face higher risks of heart disease and death. Currently, no medication is universally approved for MASH, and weight loss remains the main treatment approach. This research aims to compare the effects of metabolic surgery versus incretin-based drug therapies on liver health in patients with obesity and biopsy-confirmed MASH and liver fibrosis. Participants will be randomly assigned to one of two groups: metabolic surgery or medical treatment with incretin-based therapies such as liraglutide, semaglutide, or tirzepatide. The surgical group will undergo either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG), with the choice made by the patient and medical team based on health factors and preferences. The medication group will receive approved incretin drugs in various forms and doses, tailored to availability and clinical needs. The study will last for two years, during which patients will be monitored and will have liver biopsies before starting and at the end of the study to assess changes in liver fibrosis. Throughout the trial, about 120 adult participants with obesity and MASH will be closely followed. They will undergo liver biopsies at the start and after two years to measure fibrosis improvement using the Kleiner fibrosis classification. Researchers will also monitor weight, medication adherence, and other health indicators. Safety and treatment effects will be evaluated over the two-year period. The study is conducted at multiple centers internationally, with the main site at Cleveland Clinic in the USA.

The International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry is an ongoing global observational program tracking routine clinical outcomes in patients diagnosed with Gaucher disease. It includes patients regardless of their treatment status and aims to improve understanding of the variability, progression, and natural history of Gaucher disease. The Registry also seeks to support the medical community by developing monitoring recommendations, characterizing the patient population, and evaluating long-term treatment effectiveness of imiglucerase and eliglustat. The Registry involves no experimental treatments; patients receive clinical assessments and care as directed by their treating physicians. Additionally, there is a Gaucher Pregnancy Sub-registry that monitors pregnancy outcomes, complications, and infant growth up to 36 months postpartum for women with Gaucher disease. This Sub-registry collects medical and obstetric history and pregnancy data for participants who consent, without altering their standard care. Participants provide data through routine clinical visits, and researchers collect medical information to better understand patient outcomes and optimize care. The Registry tracks outcomes over long periods, including up to 42 years, to support ongoing care improvements. Women in the Pregnancy Sub-registry have additional data collected on pregnancy and infant growth, contributing to comprehensive monitoring of Gaucher disease impacts during and after pregnancy.

Researchers are investigating the development of type 2 diabetes and its complications in the Kuwaiti population, focusing on those who were part of the original Kuwait Diabetes Epidemiology Program (KDEP) and others at high risk. The study aims to identify risk factors that lead to prediabetes and diabetes, including genetic, biochemical, and environmental contributors, while addressing the lack of large longitudinal studies in Kuwait and the Gulf region. It also seeks to understand familial patterns of diabetes and provide data to support prevention and management strategies for obesity, diabetes, and related cardiovascular conditions. The study involves recalling approximately 3,970 non-diabetic participants from the original KDEP cohort, as well as recruiting family members and others with a family history of diabetes. Participants will undergo detailed physiological, genetic, biochemical, and environmental assessments. A subset of 250 participants will have additional tests, including oral glucose tolerance tests (OGTT), hyperglycemia clamp, and euglycemic clamp procedures. The study will measure the incidence of diabetes, prediabetes, and diabetes-related vascular complications over 4 to 7 years. Participants will be followed up with clinical evaluations, laboratory tests, and questionnaires to track the onset of diabetes and its complications. Researchers will monitor microvascular and macrovascular complications such as retinopathy, nephropathy, and neuropathy. The study also collects data to identify metabolic and molecular factors linked to disease progression. The results aim to help clinicians improve patient care and assist policymakers in developing effective health programs for diabetes prevention and control in Kuwait.

Researchers are evaluating whether resistance exercise and/or increased protein intake can help preserve lean muscle mass and improve physical function in adults with obesity who are starting treatment with semaglutide or tirzepatide. The study aims to assess the effects of these interventions during weight loss induced by these medications and also to explore any related benefits on blood sugar control, cholesterol, liver function, quality of life, physical activity, and sleep. Participants will begin semaglutide or tirzepatide therapy with gradually increasing doses to maximize weight loss. They will be randomly assigned to one of four groups: a control group, a protein intake group, a resistance exercise group, or a group receiving both resistance exercise and increased protein intake. Those in the resistance exercise group will perform exercises three times a week, with initial sessions supervised to ensure proper technique and group support meetings throughout the study. Participants in the protein intake group will aim for 1.6 grams of protein per kilogram of body weight daily, starting with two protein drinks per day for the first two weeks and adjusting intake based on dietary assessments. Participants will be followed for six months from enrollment. Researchers will measure changes in the muscle size of the quadriceps using MRI scans at the start and end of the treatment period. The study will also monitor other health markers and physical function. Regular group sessions and dietary assessments will support adherence to the interventions throughout the study period.

The Pompe Registry is a global, multicenter, international program that follows patients with Pompe disease over time. It is an observational and voluntary study designed to track the natural history and outcomes of Pompe disease in both treated and untreated patients. The registry aims to improve understanding of the disease's variability, progression, identification, and natural history, with the goal of guiding and assessing therapeutic interventions. It also supports the Pompe medical community in developing monitoring recommendations and reporting patient outcomes to optimize care. Additionally, the registry helps characterize the Pompe disease population and evaluates the long-term effectiveness of alglucosidase alfa. This study collects data retrospectively and prospectively from patients worldwide diagnosed with Pompe disease. It does not involve any specific interventions or treatments but gathers comprehensive clinical information over time. Data collection includes medical history, diagnosis details, treatment status, and other relevant health information to better understand the disease and patient experiences. Participants contribute data through regular updates that capture their disease progression and treatment outcomes. Researchers use this information to study how Pompe disease manifests and changes over time, with a maximum follow-up period of 30 years. The registry helps fulfill regulatory commitments, supports product development and reimbursement, and provides valuable information for research and patient care improvements.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.