Status:
TERMINATED
Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
Lead Sponsor:
NYU Langone Health
Conditions:
Obesity
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Total Knee Replacement (TKR) significantly improves function, pain, and overall quality of life in patients with end-stage arthritis of the knee. However, studies show that obesity increases complicat...
Eligibility Criteria
Inclusion
- BMI 35-45 kg/m2
- Any ethnicity
- Able to speak, read, and write in English
- Have knee replacement surgery already planned by the surgeon
- Plan to undergo knee replacement surgery within 3-6 months post LCD intervention
- Willing to commute to NYU Langone Weight Management Clinic at the start of the dietary intervention, midway through, and end of intervention
Exclusion
- Uncontrolled type 2 diabetes, defined as HbA1c \> 9%
- If smokes cigarettes, must go through a 6 week cessation program first
- Type 1 diabetes
- Whey protein allergies
- Soy allergies
- Anyone in whom rapid weight loss is not indicated (e.g., ESRD or cirrhosis, metabolic cancer, abnormal 3 times UL liver enzyme labs)
- Current untreated or uncontrolled eating disorder (e.g., binge eating, bulimia)
- Rheumatoid arthritis
- In case a previous knee replacement surgery was done, the participant should wait at least 1 year from previous date of surgery
- Undergoing simultaneous bilateral knee replacement
- Enrolled in a formal weight loss program
- Taking anti-obesity medications
- Coexisting psychotic conditions requiring hospitalization or more intense treatment (e.g., bipolar mood disorder, severe depression)
- Abnormal CBC, and uric acid, must be treated prior to start of intervention
- Higher than 5.5 mU/L or lower than 0.3 mU/L TSH must be treated prior to start of LCD intervention
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04015011
Start Date
July 25 2019
End Date
September 30 2021
Last Update
April 8 2022
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016