Reducing Obesity and Cartilage Compression in Knees

Obesity Clinical Trial

— ROCCK  

Official title:

Reducing Obesity and Cartilage Compression in Knees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730557
• Other study ID #: Pro00102409
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: May 17, 2024

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OA is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. Obesity is identified as a critical and potentially modifiable risk factor for the development and progression of OA. The first objective of the study is to determine the effects of obesity on cartilage composition and function. The second objective of the study is to determine whether weight loss restores cartilage composition and function. Study activities would require getting MR Imaging, evaluation of joint loading using gait analysis techniques, cartilage strain measurement, and participating in weight loss intervention. The study will target a population age group between 18 and 45 years with a BMI greater than or equal to 29. Data analyses will be blinded to reduce potential bias. All subjects participating in this study will be informed of the risks involved and sign an IRB-approved consent form.

Description:

Appropriate study power will be achieved with 35 participants in the weight loss group and 35 participants in the weight maintenance control group (see Data Analysis and Statistical Considerations). We will recruit and enroll obese (BMI ≥29 - ≤40) men and women, age 18 to 45, with no previous history of lower extremity injury, no evidence of symptoms OA, no knee misalignment (neutral alignment between 178° and 182°), or other injury that would prevent them from performing the walking task required by this study. All inclusion criteria specific to knee injury, OA, and alignment will be verified by MRI scan. All participants in this study will be informed of the risks involved. Upon expressing interest in study participation, participants will be asked questions to determine whether they are free of lower extremity injury and their height and weight will also be recorded to determine their BMI. Potential participants will be pre-screened by phone using a phone script with a list of questions. Once it is determined they meet all study inclusion criteria, they will be invited to attend a consent meeting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 17, 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI (BMI =29 - <40)

• Age between 18 - 45

Exclusion Criteria:

• History of lower extremity injury

• Evidence of symptoms of knee OA

• Knee misalignment

• Evidence of pregnancy

• Thigh unable to fit in MRI coil

• Body waist fit in MRI

• Have no metals in the body

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Obesity
• Osteoarthritis

Intervention

Behavioral:
• Weight Loss
Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine [29]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Weekly intervention sessions and activities will be delivered virtually using Microsoft Teams, Duke ZOOM or Duke Webex and led by Registered Dietitians.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in cartilage strain/thickness at 3 and 6 months	We will use MRI to detect change in cartilage strain/thickness at 3 and 6 months	Baseline, 3 months, and 6 months
Secondary	Change from baseline in cartilage composition at 3 and 6 months	We will use MRI to detect change in cartilage composition at 3 and 6 months	Baseline, 3 months, and 6 months
Secondary	Change from baseline in inflammation at 3 and 6 months	Serum and urine biomarkers will be collected to determine levels of inflammation.	Baseline, 3 months, and 6 months
Secondary	Change from baseline in cartilage degeneration at 3 and 6 months	We will use serum biomarkers to determine cartilage degeneration	Baseline, 3 months, and 6 months
Secondary	Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months	We will use serum biomarkers to determine insulin resistance and beta-cell function	Baseline, 3 months, and 6 months
Secondary	Change from baseline in muscle strength at 3 and 6 months	Isokinetic dynamometer will be used to determine peak torque of knee extensor and flexor	Baseline, 3 months, and 6 months
Secondary	Change from baseline in body weight at 3 and 6 months	Body weight as measured by Bodpod	Baseline, 3 months, and 6 months
Secondary	Change from baseline in fat mass (kg) at 3 and 6 months	Body fat mass (kg) as measured by Bodpod	Baseline, 3 months, and 6 months
Secondary	Change from baseline in fat mass (%) at 3 and 6 months	Body fat mass (%) as measured by Bodpod	Baseline, 3 months, and 6 months
Secondary	Change from baseline in lean mass (%) at 3 and 6 months	Body lean mass (%) as measured by Bodpod	Baseline, 3 months, and 6 months
Secondary	Change from baseline in lean mass (kg) at 3 and 6 months	Body lean mass (%) as measured by Bodpod	Baseline, 3 months, and 6 months
Secondary	Change from baseline in 6-minute walk (meters) at 3 and 6 months	Distanced (meters) walked in 6 minutes	Baseline, 3 months, and 6 months
Secondary	Change from baseline in umbilical waist circumference at 3 and 6 months	Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are >0.5 cm.	Baseline, 3 months, and 6 months
Secondary	Change from baseline in minimal waist circumference at 3 and 6 months	Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are >0.5 cm.	Baseline, 3 months, and 6 months
Secondary	Change from baseline in hip circumference at 3 and 6 months	Body proportions will be measured at the hip circumference using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are >0.5 cm.	Baseline, 3 months, and 6 months
Secondary	Change from baseline total calories at 3 and 6 months	Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)	Baseline, 3 months, and 6 months
Secondary	Change from baseline macronutrients at 3 and 6 months	Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)	Baseline, 3 months, and 6 months
Secondary	Change in activity (intensity levels) at 3 and 6 months	Activity intensity levels using an actigraphy device worn for 7 days at each time point	Baseline, 3 months, and 6 months
Secondary	Change in steps at 3 and 6 months	Steps will be determined using an actigraphy device worn for 7 days at each time point	Baseline, 3 months, and 6 months
Secondary	Change in Healthy Eating Index at 3 months and 6 months	Healthy Eating Index (HEI-2015) calculated from Dietary History Questionnaire III (DHQIII, National Cancer Institute) at each time point. The HEI score ranges from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans..	Baseline, 3 months, and 6 months