[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06706284":3,"trial-entities:NCT06706284":111,"trial-summary:NCT06706284":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":47,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":65,"locations":68,"central_contacts":97,"overall_officials":106,"references":109,"see_also_links":110},"NCT06706284","STUDY00000591","Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes","RECRUITING","2029-03-01","2026-04","2026-04-13","2025-04-11","Marzieh Salehi","OTHER",false,"It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.","This study consists of 7-9 in-person visits and 9-10 phone visits, and participants will be randomized to either semaglutide or placebo for 24 weeks. The participants first visit, will include review of medical history and performance of standard tests to check the participant's health and eligibility for the study. Before starting any medication, participants will have 2 more visits:\n\n* a mixed meal tolerance test, to examine their body's response to nutrient ingestion and\n* a glucose clamp study to examine insulin sensitivity. These tests will be scheduled on two separate days. Following the 3 baseline visits, participants will be randomized to either the intervention (once-weekly injection of semaglutide, also known as Ozempic, for 24 weeks) or placebo. During the 24-week intervention participants will receive 9-10 phone calls to discuss their progress and experiences with the interventions and will also be asked to return for a short research visit including interim medical history with or without blood sample collection twice. At the end of 24 weeks, the treatments will be discontinued, and participants will repeat the meal and glucose studies scheduled over two separate days. During participation, fat\u002Flean mass will be measured using DEXA and liver fat mass may be measured using fibroscan. In addition, participants may be asked for a stool sample.",[18,19],"Spinal Cord Injuries","Type 2 Diabetes",[21,22,23,24],"Glucose regulation","Semaglutide","Ozempic","Glucagon- Like Peptide 1 (GLP-1)","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},50,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Semaglutide Injectable Product","A GLP-1 inhibitor used to control T2DM",[38],"SCI and T2DM Treatment Group",[23],{"type":13,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Placebo","Saline solution will be administered with the same frequency as semaglutide and participants will be instructed how to use the saline in the same manner as the active drug group.",[44],"SCI and T2DM Placebo Group",[46],"Saline solution",[48,52],{"measure":49,"description":50,"timeFrame":51},"Glucose tolerance","The change in the incremental AUC Glucose3h response to meal ingestion","Baseline to 24 weeks",{"measure":53,"description":54,"timeFrame":51},"Insulin action","Liver, adipose tissue and muscle insulin sensitivity determined using a two-step euglycemic clamp.",[],"ALL","18 Years","70 Years",{"inclusion":60,"exclusion":61,"raw_text":64},[],[62,63],"Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within a year prior to the start of the study","Pioglitazone, SGLT2 or DPPIV inhibitors, GLP-1RA within the last 60 days at the time of screening 9. Severe allergy\u002Fhypersensitivity to any of the proposed study treatments, excipients, acetaminophen 10. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening. 11. Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which could affect the interpretation of safety and tolerability data. Prior history of bariatric surgery is not considered exclusion given the ample evidence of safety of use of GLP-1R therapy in this population. 12. Acute or chronic pancreatitis 13. Significant hepatic disease (except for metabolic dysfunction-associated steatohepatitis \\[MASH\\] or metabolic dysfunction-associated steatotic liver disease \\[MASLD\\]) without portal hypertension or cirrhosis) and\u002For subjects with any of the following results at screening:","Inclusion Criteria:\n\n1. Male and female subjects aged 18-70 years (inclusive) at screening\n2. More than one year after spinal cord injury\n3. Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.\n4. Provision of signed and dated written informed consent prior to any study specific procedures\n5. Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening\n6. HbA1c 6.0-9.0% at screening\n7. BMI \\> 22 kg\u002Fm2 at screening\n8. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating\n9. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and\u002For any subject unable or unwilling to follow study procedures.\n2. Any subject who has received another investigational product as part of a clinical study within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening\n3. Taking mirabegron or other glucose altering medications\n4. Taking steroids within the past 1 year\n5. Significant anemia (hemoglobin\\\u003C11g\u002FdL)\n6. History of gastric outlet obstruction or chronic diarrhea\n7. History of a chronic neurological illness other than SCI (i.e.; MS, etc)\n8. Any subject who has received any of the following medications within the specified time-frame prior to the start of the study\n\n   * Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within a year prior to the start of the study\n   * Pioglitazone, SGLT2 or DPPIV inhibitors, GLP-1RA within the last 60 days at the time of screening\n9. Severe allergy\u002Fhypersensitivity to any of the proposed study treatments, excipients, acetaminophen\n10. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening.\n11. Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which could affect the interpretation of safety and tolerability data. Prior history of bariatric surgery is not considered exclusion given the ample evidence of safety of use of GLP-1R therapy in this population.\n12. Acute or chronic pancreatitis\n13. Significant hepatic disease (except for metabolic dysfunction-associated steatohepatitis \\[MASH\\] or metabolic dysfunction-associated steatotic liver disease \\[MASLD\\]) without portal hypertension or cirrhosis) and\u002For subjects with any of the following results at screening:\n\n    Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN) Alanine transaminase (ALT) ≥ 3 × ULN Total bilirubin ≥ 2 × ULN\n14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fminute\u002F1.73m2 at screening (GFR estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable \\[SI units\\])\n15. Unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA) or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening\n16. Severe congestive heart failure (New York Heart Association Class III or IV)\n17. Basal calcitonin level \\> 50 ng\u002FL at screening or history\u002Ffamily history of medullary thyroid carcinoma or multiple endocrine neoplasia\n18. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer\n19. History of HIV infection or other immune compromised disease; and history of organ transplantation\n20. Substance dependence or history of alcohol abuse and\u002For excess alcohol intake\n21. Patients on ketogenic diet",[66,67],"ADULT","OLDER_ADULT",[69,89],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":86},"University Health - Texas Diabetic Institute","San Antonio","Texas","78207","United States",[76,80,83],{"name":77,"role":78,"email":79},"Matthew A Davis","CONTACT","davism13@uthscsa.edu",{"name":81,"role":78,"email":82},"Mooney Mark-Johnson","markjohnson@uthscsa.edu",{"name":84,"role":85},"Marzieh Salehi, MD, MS","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},29.42412,-98.49363,{"facility":90,"status":7,"city":71,"state":72,"zip":91,"country":74,"contacts":92,"geoPoint":96},"University of Texas Health Science Center at San Antonio","78229",[93,94,95],{"name":77,"role":78,"email":79},{"name":81,"role":78,"email":82},{"name":84,"role":85},{"lat":87,"lon":88},[98,102],{"name":99,"role":78,"phone":100,"email":101},"Marzieh Salehi, MD","210-567-6691","salehi@uthscsa.edu",{"name":103,"role":78,"phone":104,"email":105},"Andrea Hansis-Diarte, MPh","210 567 3208","hansisdiarte@uthscsa.edu",[107],{"name":99,"affiliation":108,"role":85},"The University of Texas Health Science Center at San Antonio",[],[],{"nct_id":4,"conditions":112,"biomarkers":115},[113,114],"Spinal Cord Injury","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an interventional study with 50 participants who will be randomly assigned to receive either semaglutide or a placebo (inactive saline solution) for 24 weeks.","completed","GLP-1R Agonist Therapy for Type 2 Diabetes in Spinal Cord Injury","This study is investigating whether semaglutide (also known as Ozempic), a medication used to control type 2 diabetes, is effective for people with spinal cord injury (SCI) who also have type 2 diabetes. People with SCI are at higher risk for this condition. You could be eligible if you are 18-70 years old, had a spinal cord injury more than one year ago, and have type 2 diabetes. The study will look at how semaglutide affects your blood sugar levels and other information related to type 2 diabetes and obesity. The study aims to see if semaglutide improves glucose tolerance (how your body handles sugar) and insulin action (how well your body uses insulin) over 24 weeks. The current status of this study is unclear.","After the 24-week treatment period, you will repeat the meal and glucose studies over two separate days.",125,"You would have 7-9 in-person visits and 9-10 phone visits over 24 weeks, including medical history reviews, blood tests, and specialized tests like a mixed meal tolerance test and a glucose clamp study.","Not stated in the trial record.",[],"v2"]