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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04730557
Other study ID # Pro00102409
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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Day JS, Ding M, van der Linden JC, Hvid I, Sumner DR, Weinans H. A decreased subchondral trabecular bone tissue elastic modulus is associated with pre-arthritic cartilage damage. J Orthop Res. 2001 Sep;19(5):914-8. doi: 10.1016/S0736-0266(01)00012-2. — View Citation

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Felson DT, Zhang Y, Anthony JM, Naimark A, Anderson JJ. Weight loss reduces the risk for symptomatic knee osteoarthritis in women. The Framingham Study. Ann Intern Med. 1992 Apr 1;116(7):535-9. doi: 10.7326/0003-4819-116-7-535. — View Citation

Felson DT. Does excess weight cause osteoarthritis and, if so, why? Ann Rheum Dis. 1996 Sep;55(9):668-70. doi: 10.1136/ard.55.9.668. No abstract available. — View Citation

Felson DT. Relation of obesity and of vocational and avocational risk factors to osteoarthritis. J Rheumatol. 2005 Jun;32(6):1133-5. No abstract available. — View Citation

Felson DT. Weight and osteoarthritis. Am J Clin Nutr. 1996 Mar;63(3 Suppl):430S-432S. doi: 10.1093/ajcn/63.3.430. — View Citation

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Griffin TM, Guilak F. Why is obesity associated with osteoarthritis? Insights from mouse models of obesity. Biorheology. 2008;45(3-4):387-98. — View Citation

Grotle M, Hagen KB, Natvig B, Dahl FA, Kvien TK. Obesity and osteoarthritis in knee, hip and/or hand: an epidemiological study in the general population with 10 years follow-up. BMC Musculoskelet Disord. 2008 Oct 2;9:132. doi: 10.1186/1471-2474-9-132. — View Citation

Hollis JF, Gullion CM, Stevens VJ, Brantley PJ, Appel LJ, Ard JD, Champagne CM, Dalcin A, Erlinger TP, Funk K, Laferriere D, Lin PH, Loria CM, Samuel-Hodge C, Vollmer WM, Svetkey LP; Weight Loss Maintenance Trial Research Group. Weight loss during the intensive intervention phase of the weight-loss maintenance trial. Am J Prev Med. 2008 Aug;35(2):118-26. doi: 10.1016/j.amepre.2008.04.013. — View Citation

Kopec JA, Rahman MM, Berthelot JM, Le Petit C, Aghajanian J, Sayre EC, Cibere J, Anis AH, Badley EM. Descriptive epidemiology of osteoarthritis in British Columbia, Canada. J Rheumatol. 2007 Feb;34(2):386-93. Epub 2006 Dec 15. — View Citation

Kretzer JP, Jakubowitz E, Sonntag R, Hofmann K, Heisel C, Thomsen M. Effect of joint laxity on polyethylene wear in total knee replacement. J Biomech. 2010 Apr 19;43(6):1092-6. doi: 10.1016/j.jbiomech.2009.12.016. Epub 2010 Jan 13. — View Citation

Lahuec C, Almouahed S, Arzel M, Gupta D, Hamitouche C, Jezequel M, Stindel E, Roux C. A self-powered telemetry system to estimate the postoperative instability of a knee implant. IEEE Trans Biomed Eng. 2011 Mar;58(3):822-5. doi: 10.1109/TBME.2010.2069099. Epub 2010 Aug 30. — View Citation

Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176. — View Citation

Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139. — View Citation

Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, Ettinger WH Jr, Pahor M, Williamson JD. Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, Diet, and Activity Promotion Trial. Arthritis Rheum. 2004 May;50(5):1501-10. doi: 10.1002/art.20256. — View Citation

Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, DeVita P, Beavers DP, Hunter DJ, Lyles MF, Eckstein F, Williamson JD, Carr JJ, Guermazi A, Loeser RF. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 2013 Sep 25;310(12):1263-73. doi: 10.1001/jama.2013.277669. — View Citation

Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021. — View Citation

Oliveria SA, Felson DT, Cirillo PA, Reed JI, Walker AM. Body weight, body mass index, and incident symptomatic osteoarthritis of the hand, hip, and knee. Epidemiology. 1999 Mar;10(2):161-6. — View Citation

Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24. — View Citation

Powell A, Teichtahl AJ, Wluka AE, Cicuttini FM. Obesity: a preventable risk factor for large joint osteoarthritis which may act through biomechanical factors. Br J Sports Med. 2005 Jan;39(1):4-5. doi: 10.1136/bjsm.2004.011841. — View Citation

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Seagle HM, Strain GW, Makris A, Reeves RS; American Dietetic Association. Position of the American Dietetic Association: weight management. J Am Diet Assoc. 2009 Feb;109(2):330-46. doi: 10.1016/j.jada.2008.11.041. — View Citation

Serebrakian AT, Poulos T, Liebl H, Joseph GB, Lai A, Nevitt MC, Lynch JA, McCulloch CE, Link TM. Weight loss over 48 months is associated with reduced progression of cartilage T2 relaxation time values: data from the osteoarthritis initiative. J Magn Reson Imaging. 2015 May;41(5):1272-1280. doi: 10.1002/jmri.24630. Epub 2014 Apr 4. — View Citation

Streit KJ, Stevens NH, Stevens VJ, Rossner J. Food records: a predictor and modifier of weight change in a long-term weight loss program. J Am Diet Assoc. 1991 Feb;91(2):213-6. — View Citation

Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available. Erratum In: J Am Diet Assoc. 2003 May;103(5):563. — View Citation

Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27. — View Citation

* Note: There are 31 references in allClick 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
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