Status:
COMPLETED
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
Lead Sponsor:
VA Office of Research and Development
Conditions:
Prediabetes
Obesity
Eligibility:
MALE
55+ years
Phase:
NA
Brief Summary
Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as we...
Detailed Description
This study examines an evidence-based obesity intervention as a means of reducing the impact of prediabetes on muscle function in obese older men of white and black race. A total of 64 obese (BMI 30 k...
Eligibility Criteria
Inclusion
- Male Veterans
- African American or Caucasian
- Obese (BMI \> 30 kg/m2)
- Age 55+ years
- Pre-diabetes (confirmed fasting plasma glucose 100 and \<126 mg/dL) or HbA1c 5.7-6.4%
- Short Physical Performance Battery score of 4 to 11 units
- Age-normal renal function
- English speaking
- Able to record dietary intake or has a proxy who can record dietary intake
- Willing and able to be randomized to either intervention group
Exclusion
- Presence of unstable or symptomatic life-threatening illness
- Glomerular filtration rates (GFR) less than 45 mL/min
- A GFR of 45-59 requires bi-monthly testing per the investigators' established algorithm
- Those with a GFR \<45 mL/min are excluded
- Mini Cog score of \<3
- -Vegetarian
- Neurological conditions causing functional impairments, including:
- Parkinson's Disease
- multiple sclerosis
- permanent disability due to stroke
- Inability to complete physical function assessment
- History of significant weight instability
- Contraindicated medications, including narcotic mail-outs and active substance abuse
- Any psychiatric condition that would prevent the subject from participating in a group intervention setting, including diagnosed personality disorders
- Primary care provider disapproves participation
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03835416
Start Date
December 12 2019
End Date
March 31 2024
Last Update
June 6 2025
Active Locations (1)
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1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875