Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 16, 2023

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Veteran, age 18 to 89 years old
• • The Syracuse SCI registry includes adults only, so the youngest age of enrollment is 18. The effects of fasting on age-induced sarcopenia remain "uncertain"; therefore, the investigators will cap the age at 89 years old
• • A member of the Spinal Cord Injury/Disorder (SCI/D) registry through the Syracuse VA, including both hub and spoke sites
• • A qualifying diagnosis of SCI within the SCI/D registry
• • Neurologic level of injury from T1 to S5, based on most recent Status Update or ASIA examination, or a diagnosis of a hereditary form of paraplegia (such as familial spastic paraplegia or hereditary spastic paraplegia)
• • ASIA Impairment Scale grade A-D
• • Chronic SCI (\> 1 year from date of SCI or diagnosis of SCI)
• • BMI \> 22 - the BMI used to diagnose obesity in individuals with SCI
• • Mean eating window of at least 10 hours per day
• Exclusion Criteria:
• • Females who are pregnant (tested via urinary hCG), planning to become pregnant in the next 6 months, or breast-feeding
• • A member of the SCI/D registry through the Syracuse VA, with a qualifying diagnosis of MS or ALS
• • Diagnosis of heart failure
• • Diagnosis of diabetes mellitus, type 1
• • Diagnosis of diabetes mellitus, type 2, and on insulin or other antidiabetic agent with high incidence of hypoglycemia
• • o Of note, antidiabetic agents with low incidence of hypoglycemia are: metformin, GLP-1 receptor agonists, SGLT2 inhibitors, DPP4 inhibitors, alpha glucosidase inhibitors, thiazolidinediones (as discussed with VA pharmacist)
• • Diagnosis of End Stage Renal Disease
• • Diagnosis of dementia
• • Diagnosis of orthostatic hypotension and prescribed midodrine or fludrocortisone
• • History of syncopal episode in the month prior to the study
• • History of significant weight loss (\> 10% body weight) in the month prior to the study
• • History of eating disorders (e.g., anorexia or bulimia) within the last five years, or clearance from a mental health provider
• • History of active suicidal ideation in the last six months, or clearance from a mental health provider
• • Currently prescribed weight loss medication (e.g., liraglutide)
• • Currently prescribed corticosteroids
• • Current acute medical issues including cancer, sepsis, advanced liver failure, porphyria, or uncontrolled hyperthyroidism