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Completed

NCT Number: NCT04730557

Reducing Obesity and Cartilage Compression in Knees

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.

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Key information

Conditions

Obesity Arthritis Body Weight Body Weight Changes Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoarthritis Osteoarthritis, Knee Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss

Behavioral

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.

Primary outcomes

  1. Change from baseline in cartilage strain/thickness at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    We will use MRI to detect change in cartilage strain/thickness at 3 and 6 months

Secondary outcomes

  1. Change from baseline in cartilage composition at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    We will use MRI to detect change in cartilage composition at 3 and 6 months

  2. Change from baseline in inflammation at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Serum and urine biomarkers will be collected to determine levels of inflammation.

  3. Change from baseline in cartilage degeneration at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    We will use serum biomarkers to determine cartilage degeneration

  4. Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    We will use serum biomarkers to determine insulin resistance and beta-cell function

  5. Change from baseline in muscle strength at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Isokinetic dynamometer will be used to determine peak torque of knee extensor and flexor

  6. Change from baseline in body weight at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Body weight as measured by Bodpod

  7. Change from baseline in fat mass (kg) at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Body fat mass (kg) as measured by Bodpod

  8. Change from baseline in fat mass (%) at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Body fat mass (%) as measured by Bodpod

  9. Change from baseline in lean mass (%) at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Body lean mass (%) as measured by Bodpod

  10. Change from baseline in lean mass (kg) at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Body lean mass (%) as measured by Bodpod

  11. Change from baseline in 6-minute walk (meters) at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Distanced (meters) walked in 6 minutes

  12. Change from baseline in umbilical waist circumference at 3 and 6 months

    Time frame: Baseline, 3 months, 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.

  13. Change from baseline in minimal waist circumference at 3 and 6 months

    Time frame: Baseline, 3 months, 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.

  14. Change from baseline in hip circumference at 3 and 6 months

    Time frame: Baseline, 3 months, 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.

  15. Change from baseline total calories at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)

  16. Change from baseline macronutrients at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)

  17. Change in activity (intensity levels) at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Activity intensity levels using an actigraphy device worn for 7 days at each time point

  18. Change in steps at 3 and 6 months

    Time frame: Baseline, 3 months, and 6 months

    Steps will be determined using an actigraphy device worn for 7 days at each time point

  19. Change in Healthy Eating Index at 3 months and 6 months

    Time frame: Baseline, 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..

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: ROCCK

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 29, 2021
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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