Clinical trial NCT05921487: Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
Official title: Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injury
Obesity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-06-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention: This is a single-arm study in a convenience sample of Veterans with paraplegia and obesity.

Research Design: Those with mean eating windows of at least 10 hours per day will be eligible to participate in the TRE intervention. Tests for adherence (food log) will be collected.
Primary purpose: OTHER

Brief summary: Spinal cord injury (SCI) causes paralysis and muscle atrophy and leads to weight gain and obesity. Obesity directly contributes to functional impairment and cardiometabolic dysfunction. There is a critical need to reduce the growing prevalence of obesity and cardiometabolic disease after SCI. My overall objective in this project is to gather crucial feasibility data on time restricted eating (TRE), a novel form of intermittent fasting. TRE is a straightforward method to induce weight loss without the need for calorie counting. TRE allows individuals to eat all their daily calories in a time restricted window and fast outside that window. A growing body of literature supports the safety and efficacy of TRE. Given the feasibility, high adherence, and substantial benefits of TRE in able-bodied individuals, it is important to test TRE to determine its feasibility in Veterans with SCI. The investigators will first test this intervention in Veterans with paraplegia, who are at greatest risk of muscle-joint upper body injury given the need to support body weight during activity. The investigators will determine adherence to a TRE window for 6-weeks duration in a convenience sample of Veterans with paraplegia and obesity. Based on the expected outcomes of good adherence, this study will lay the groundwork for future work by informing the design of a randomized controlled trial to test the efficacy of TRE to facilitate weight loss and improve function.


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

Primary outcomes:
measure: Change in the daily eating window
timeFrame: Measured weekly from baseline to week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: Syracuse VA Medical Center, Syracuse, NY
name: Geoffrey V Henderson, MD
role: PRINCIPAL_INVESTIGATOR
References: