Clinical trial

UTSW NORC Pilot Spinal Cord Injury Dietary Program

Recruiting now · Not applicable · 1 countries · Registry ID NCT06924177

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Obesity-related Medical Conditions, Spinal Cord Injury, Chronic

Full registry criteria

Inclusion Criteria: * age 18-65 years old * have had SCI for more than one year * not independently ambulatory * primarily uses a wheelchair for mobility * community-dwelling * without comorbidities listed in the exclusion criteria Exclusion Criteria: * 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.

Treatments and study arms

Telehealth with dietician

Other

9 weeks of telehealth visit with dietician using the DPP diet modules

Primary outcomes

body fat compositionfrom enrollment to 9 weeks after completion of the modified DPP-diet program

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.

Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR)from enrollment to 9 weeks after completion of the modified DPP-diet program

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Texas Southwestern Medical Center🇺🇸 Dallas, Texas, United States

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Yi-Ting TzenContact

Email · Call 214-648-1786