Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 10 visits, 2 visits, 3 visits
- Time periods mentioned: 24 weeks
- Procedures mentioned: Phone or video check-ins, Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Before starting any medication, participants will have 2 more visits: * a mixed meal tolerance test, to examine their body's response to nutrient ingestion and * a glucose clamp study to examine insulin sensitivity."
- "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."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how semaglutide, a diabetes drug, affects blood sugar and weight. It is for adults with type 2 diabetes who have had a spinal cord injury for more than one year.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–70 years old.
- Your spinal cord injury happened more than one year ago, is at level C2–L2, and has an ASIA grade of A, B, C, or D. These describe the injury's location and effects.
- You sign a consent form before any study procedures.
- You manage type 2 diabetes with diet and metformin only. Your metformin dose has not changed by 50% or more in the past 3 months.
- Your HbA1c, a measure of average blood sugar, is 6.0–9.0%.
- Your BMI, a measure of weight compared with height, is above 22.
- If you can become pregnant, you must have negative pregnancy tests at screening and group assignment and must not be breastfeeding.
- If you can become pregnant and have sex with a male partner who is not sterilized, you must use highly effective birth control from screening through the study's end. Rhythm and withdrawal methods do not count.
Who can't join
- A condition makes the study unsafe or affects its results, or you cannot or will not follow study steps. Recent use of another study drug also excludes you: within 30 days or 5 drug half-lives, whichever is longer.
- You take mirabegron or other blood sugar-changing drugs; used steroids or weight-control drugs or herbs within a year; or used pioglitazone, SGLT2 or DPPIV inhibitors, or GLP-1 drugs within 60 days.
- You have type 1 diabetes, past diabetic ketoacidosis (dangerous acid buildup), signs of suddenly poor blood sugar control, or daily insulin injections within 90 days. A ketogenic diet also excludes you.
- You have significant anemia (hemoglobin below 11), another long-term brain or nerve disease, HIV or another condition that weakens immunity, an organ transplant, substance dependence, or alcohol abuse or heavy drinking.
- You have a blocked stomach outlet, long-term diarrhea, major bowel inflammation, serious upper digestive tract disease or surgery, or an inflamed pancreas. Past weight-loss surgery alone does not exclude you.
- You have serious liver disease or certain high liver blood tests, or kidney function below 45 on an eGFR test. Some fatty liver conditions without liver scarring or high pressure in liver veins are allowed.
- You have severe heart failure; unstable chest pain, heart attack, mini-stroke, or stroke within 3 months; or a heart artery procedure within 6 months or planned now.
- You have a severe allergy to study treatments, their ingredients, or acetaminophen; calcitonin above 50; a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (a tumor disorder); or cancer within 5 years, except certain treated skin or early cervical cancers.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Male and female subjects aged 18-70 years (inclusive) at screening 2. More than one year after spinal cord injury 3. Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D. 4. Provision of signed and dated written informed consent prior to any study specific procedures 5. 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 6. HbA1c 6.0-9.0% at screening 7. BMI \> 22 kg/m2 at screening 8. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating 9. 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. Exclusion Criteria: 1. 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/or any subject unable or unwilling to follow study procedures. 2. 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 3. Taking mirabegron or other glucose altering medications 4. Taking steroids within the past 1 year 5. Significant anemia (hemoglobin\<11g/dL) 6. History of gastric outlet obstruction or chronic diarrhea 7. History of a chronic neurological illness other than SCI (i.e.; MS, etc) 8. Any subject who has received any of the following medications within the specified time-frame prior to the start of the study * 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/hypersensitivity 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/or subjects with any of the following results at screening: Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN) Alanine transaminase (ALT) ≥ 3 × ULN Total bilirubin ≥ 2 × ULN 14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) \< 45 mL/minute/1.73m2 at screening (GFR estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable \[SI units\]) 15. 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 16. Severe congestive heart failure (New York Heart Association Class III or IV) 17. Basal calcitonin level \> 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia 18. 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 19. History of HIV infection or other immune compromised disease; and history of organ transplantation 20. Substance dependence or history of alcohol abuse and/or excess alcohol intake 21. Patients on ketogenic diet
Study sites (2)
TX
- University Health - Texas Diabetic Institute · San Antonio, TX 78207Hector Gonzalez Cantu, PhD · Study contact · 2105676707 · gonzalezcant@uthscsa.eduMooney Mark-Johnson · Study contact · markjohnson@uthscsa.eduMarzieh Salehi, MD, MS · Principal investigatorMore trials in San Antonio
- University of Texas Health Science Center at San Antonio · San Antonio, TX 78229Hector Gonzalez Cantu, PhD · Study contact · 2105676707 · gonzalezcant@uthscsa.eduMooney Mark-Johnson · Study contact · markjohnson@uthscsa.eduMarzieh Salehi, MD, MS · Principal investigatorMore trials in San Antonio