RECRUITING

Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

Conditions

Spinal Cord Injuries Type 2 Diabetes Glucose regulation Semaglutide Ozempic Glucagon- Like Peptide 1 (GLP-1)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

Quick Facts

Study Start:2025-01

Study Completion:2029-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06706284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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 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: 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

Inclusion Criteria

Exclusion 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.

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
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:
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

Contacts and Locations

Study Contact

Marzieh Salehi, MD

CONTACT

210-567-6691

salehi@uthscsa.edu

Principal Investigator

Marzieh Salehi, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

University Health - Texas Diabetic Institute

San Antonio, Texas, 78207

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Marzieh Salehi

Marzieh Salehi, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2029-01

Study Record Updates

Study Start Date2025-01

Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

Glucose regulation
Semaglutide
Ozempic
Glucagon- Like Peptide 1 (GLP-1)

Additional Relevant MeSH Terms

Spinal Cord Injuries
Type 2 Diabetes