UTSW NORC Pilot Spinal Cord Injury Dietary Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity.
The main question it aims to answer is:
Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance?
Participants will:
Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet.
Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18-65 years old
have had SCI for more than one year
not independently ambulatory
primarily uses a wheelchair for mobility
Disqualifiers
uncontrolled type 2 diabetes mellitus
pregnancy
active systemic disease, e.g., heart disease, real failure/insufficiency, multiple myeloma, lupus with nephropathy, sickle cell disease, symptomatic myasthenia gravis, poorly controlled hypo- or hyperthyroidism.
Trial design
Design model
Single group
Treatments tested in this trial
Telehealth with dietician
Other intervention9 weeks of telehealth visit with dietician using the DPP diet modules
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: ExperimentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
body fat composition
Whole body fat percentage from dual-energy X-ray absorptiometry scan. The unit will be %, with higher value indicating larger amount of body fat within an individual.
Time frame
from enrollment to 9 weeks after completion of the modified DPP-diet program2
Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR)
An insulin resistance index calculated from fasting glucose (mmol/l) and insulin (μU/ml) level from blood draw. The HOMA2-IR will be calculated using the formula: HOMA2-IR = (Fasting Insulin (μU/ml) \* Fasting Glucose (mmol/L)) / 22.5.
Time frame
from enrollment to 9 weeks after completion of the modified DPP-diet programSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov