[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717554":3,"trial-entities:NCT07717554":101,"trial-summary:NCT07717554":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":62,"locations":65,"central_contacts":81,"overall_officials":85,"references":89,"see_also_links":100},"NCT07717554","STUDY20250832","Effect of Virtual Yoga in Diabetic Gastroparesis Patients","The Effect of Virtual Yoga Intervention on Symptom Severity and Quality of Life in Patients With Diabetic Gastroparesis","RECRUITING","2028-12-31","2026-07","2026-07-21","2026-07-17","Ohio State University","OTHER",false,"The purpose of this study is to investigate the potential benefits of an online yoga module for patients with gastroparesis. Specifically, the study aims to:\n\n1. Evaluate the Impact of Yoga Practices: Examine whether practicing yoga, including pranayama (breathing techniques), mindfulness meditation, and guided relaxation, can help reduce symptoms of gastroparesis, such as nausea, vomiting, bloating, and abdominal pain.\n2. Assess Psychological Factors: Determine if the yoga intervention can improve associated psychological factors, including mental well-being, sleep quality, and overall quality of life for individuals with gastroparesis.\n3. Provide Evidence-Based Insights: Contribute to the evidence base on the effectiveness of non-pharmacological treatments like yoga in managing gastroparesis, which may offer an additional, accessible management option for patients.","Diabetic gastroparesis (DGP), a chronic complication of diabetes mellitus, is characterized by delayed gastric emptying without evidence of mechanical obstruction. It results from a complex interplay of factors, including hyperglycemia-induced vagal nerve dysfunction, and impaired gastric motility. DGP predominantly affects individuals with long-standing diabetes, particularly those with poor glycemic control or diabetic neuropathy .\n\nThe condition presents with a constellation of symptoms, including nausea, vomiting, bloating, early satiety and abdominal pain, which significantly impair quality of life . Beyond its physiological burden, DGP often leads to psychological distress, mental well-being, anxiety, depression, and sleep disorders.\n\nConventional management of DGP encompasses dietary modifications, pharmacological treatments, and invasive interventions. Small, frequent meals and low-fat, low-fiber diets are often recommended to minimize symptom severity. Pharmacological therapies, such as prokinetic agents (e.g., metoclopramide, domperidone) and antiemetics, provide symptomatic relief but are limited by side effects and inconsistent efficacy. In refractory cases, interventions like gastric electrical stimulation may be employed. Despite these measures, most patients experience incomplete relief, highlighting the need for novel, holistic approaches to management.\n\nIn addition to conventional therapies, complementary and alternative approaches like acupressure, a non-invasive technique, have been explored as a potential intervention for gastroparesis. Studies suggest that acupressure points such as (P6) and (ST36), can improve gastric motility and reduce symptoms like nausea and vomiting by modulating vagal activity and enhancing gastric peristalsis.\n\nYoga, another integrative therapy, has also demonstrated efficacy in addressing gastrointestinal disorders such as irritable bowel syndrome (IBS) and functional dyspepsia. Yoga-based intervention has shown promising results in improving autonomic regulation and managing diabetic neuropathy through yoga.\n\nGiven its multifaceted benefits, when combined with standard care, yoga-based interventions can significantly enhance autonomic function, improve glycemic control, and reduce the severity of neuropathic symptoms in patients with diabetes mellitus. These findings suggest that yoga may have a beneficial role in managing the symptom severity and quality of life in gastrointestinal complications such as diabetic gastroparesis.\n\nIn this study, we will evaluate the effect of a virtual yoga module on physical and psychological symptoms and quality of life of patients with diabetic gastroparesis. This study will fill a critical gap in whether an ancient holistic practice like Yoga has any effect on physical and mental health of these patients.",[19],"Diabetic Gastroparesis",[21,22,23,24,25],"yoga","diabetic gastroparesis","virtual yoga","quality of life","gastroparesis symptom severity","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},240,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Virtual Yoga","Participants will complete gentle Yoga exercises led by a trained Yoga Instructor. Sessions will be conducted over Zoom or Teams.",[39,40],"Waitlist group","Yoga Group",[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in Gastroparesis Symptoms","Measured using the Gastroparesis Symptom Questionnaire","Comparing symptoms after 3 months of Yoga to that at baseline",{"measure":47,"description":48,"timeFrame":49},"Physical and Mental Quality of Life","Using SF-12 QOL questionnaire, we will measure the physical and mental QOL of participants at baseline and 3 months after starting Yoga sessions","From baseline to 3 months after starting virtual Yoga Sessions",[],"ALL","18 Years","65 Years",{"inclusion":55,"exclusion":58,"raw_text":61},[56,57],"History of type 1 or type 2 diabetes Gastroparesis defined by documented delayed gastric emptying, assessed by a 4-hour gastric emptying test showing more than 10% retained food in the stomach after 4 hours. This test must have been performed clinically before study enrolment.","Experiencing at least moderate Gastroparesis symptoms",[59,60],"Patients with severe depression or severe anxiety as assessed by screening questionnaire. Patients with Active inflammatory bowel disease. Participants with abdominal surgeries within the last 3 months. Severe Co-morbidities: Presence of severe comorbid conditions (e.g., advanced cardiovascular or respiratory disease) that could interfere with participation in the yoga intervention. Patients who self-report with current Pregnancy and Breastfeeding","Regular yoga practitioners (more than once a week) in the last 6 months. Undergoing current treatment for any cancer.","Inclusion Criteria:\n\n* History of type 1 or type 2 diabetes Gastroparesis defined by documented delayed gastric emptying, assessed by a 4-hour gastric emptying test showing more than 10% retained food in the stomach after 4 hours. This test must have been performed clinically before study enrolment.\n* Experiencing at least moderate Gastroparesis symptoms\n\nExclusion Criteria:\n\n* Patients with severe depression or severe anxiety as assessed by screening questionnaire. Patients with Active inflammatory bowel disease. Participants with abdominal surgeries within the last 3 months. Severe Co-morbidities: Presence of severe comorbid conditions (e.g., advanced cardiovascular or respiratory disease) that could interfere with participation in the yoga intervention. Patients who self-report with current Pregnancy and Breastfeeding\n* Regular yoga practitioners (more than once a week) in the last 6 months. Undergoing current treatment for any cancer.",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Ohio State University Wexner Medical Center","Columbus","Ohio","43210","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Subhankar Chakraborty, MD, Ph.D.","CONTACT","614-293-6255'","subhankar.chakraborty@osumc.edu",{"lat":79,"lon":80},39.96118,-82.99879,[82],{"name":83,"role":75,"phone":76,"email":84},"SUBHANKAR CHAKRABORTY, M.D., Ph.D.","Subhankar.chakraborty@osumc.edu",[86],{"name":87,"affiliation":13,"role":88},"Subhankar CHAKRABORTY, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[90,94,97],{"pmid":91,"type":92,"citation":93},"34624355","BACKGROUND","Ye Y, Yin Y, Huh SY, Almansa C, Bennett D, Camilleri M. Epidemiology, Etiology, and Treatment of Gastroparesis: Real-World Evidence From a Large US National Claims Database. Gastroenterology. 2022 Jan;162(1):109-121.e5. doi: 10.1053\u002Fj.gastro.2021.09.064. Epub 2021 Oct 6.",{"pmid":95,"type":92,"citation":96},"35618329","D'Silva A, Marshall DA, Vallance J, Nasser Y, Rajagopalan V, MacKean G, Raman M. Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study). BMJ Open. 2022 May 26;12(5):e059604. doi: 10.1136\u002Fbmjopen-2021-059604.",{"pmid":98,"type":92,"citation":99},"38947647","Kumar R, Dhamija P, Vardhan G, Kant R, Singh Y, Yadav RK, Rudra B, Pathania M. Evaluating Yoga-Based Intervention Versus the American Diabetes Association Exercise Regimen in Conjunction With Standard Care for Autonomic Neuropathy in Diabetes Mellitus: An Exploratory Clinical Trial. Cureus. 2024 May 29;16(5):e61329. doi: 10.7759\u002Fcureus.61329. eCollection 2024 May.",[],{"nct_id":4,"conditions":102,"biomarkers":103},[19],[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 240 participants.","completed","Virtual Yoga for Diabetic Gastroparesis","This study is looking at whether virtual yoga can help people with diabetic gastroparesis. Gastroparesis is a condition where your stomach empties food too slowly, causing symptoms like nausea, vomiting, bloating, and stomach pain. You could be eligible if you are between 18 and 65 years old, have type 1 or type 2 diabetes, and have a confirmed diagnosis of gastroparesis. Researchers want to see if virtual yoga sessions, including breathing exercises and relaxation, can reduce your symptoms and improve your overall quality of life and mental well-being. The study aims to enroll 240 participants, but its current status is unclear.","Your symptoms and quality of life will be assessed for 3 months after starting the virtual yoga sessions.",101,"You would participate in gentle yoga exercises led by an instructor online. Symptoms and quality of life will be measured at the start and after 3 months of virtual yoga sessions.","Not stated in the trial record.",[36],"v2"]