Reducing Obesity and Cartilage Compression in Knees

NCT04730557 | Completed

• 1 other identifier: Pro00102409
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Osteoarthritis; Knee Osteoarthritis

Keywords

Weight Loss; MRI; Arthritis; Knee Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change from baseline in cartilage composition at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from baseline in inflammation at 3 and 6 months

  Baseline, 3 months, and 6 months

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

  Baseline, 3 months, and 6 months

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

  Baseline, 3 months, and 6 months

• Change from baseline in muscle strength at 3 and 6 months

  Baseline, 3 months, and 6 months

Study Arms (2)

Weight-Loss

EXPERIMENTAL

Participants in the weight-loss intervention arm of the study will be enrolled in an individualized 6-month intervention designed to achieve a 10% reduction of body weight relative to baseline. 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. Intervention activities include individual diet counseling, group support, goal setting, self-monitoring, stress management, and problem solving. Weekly group support and education sessions, along with daily food journaling and weekly weigh-ins, are recognized approaches for successful weight loss \[30-32\]. Once the weight loss goal is achieved, diets will be liberalized for weight maintenance.

Behavioral: Weight Loss

Wellness Education

NO INTERVENTION

Control participants will be counseled to maintain their baseline body weight and level of physical activity. They will report weights weekly and if their weight deviates from baseline they will be asked to keep daily food logs and counseled to return calorie intakes to weight maintenance level. To document diet intakes/adherence, 3-day food records will be collected at months 0, 3, and 6 and analyzed for calorie and nutrient composition. Participants will be encouraged not to change their physical activity levels from baseline and their activity will be monitored by Actigraph activity monitors worn in 7-day periods at months 0, 3, and 6. In addition, each participant will be invited to enter the weight loss intervention after completion of the health education control course.

Interventions

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.

Weight-Loss

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI (BMI ≥29 - \<40)
• Age between 18 - 45

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Obesity; Osteoarthritis; Osteoarthritis, Knee; Weight Loss; Arthritis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Body Weight Changes

Study Officials

• Lou DeFrate

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: June 5, 2020
• Primary Completion: October 26, 2023
• Study Completion: May 17, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)