What side effects are associated with this type of intervention?

Common treatments for obesity include lifestyle interventions, pharmacologic therapies, and bariatric surgery. Lifestyle interventions, such as diet and exercise, generally have minimal side effects but may include temporary discomfort or injury. Pharmacologic treatments like semaglutide and naltrexone/bupropion can cause gastrointestinal issues, such as nausea and diarrhea, and may have other side effects like mood changes. Bariatric surgery, while effective, carries risks such as surgical complications, nutrient deficiencies, and gastrointestinal symptoms.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide and liraglutide, which are glucagon-like peptide-1 (GLP-1) receptor agonists. Semaglutide, in particular, has been shown to result in significant weight loss in clinical trials, such as the STEP trials. These drugs work by enhancing satiety and reducing appetite, thereby aiding in weight loss. Other FDA-approved medications for obesity include orlistat, which reduces fat absorption, and phentermine-topiramate, which suppresses appetite. These treatments are often used in conjunction with lifestyle interventions like diet and exercise to achieve better outcomes.

What other types of research exist?

Promising novel alternatives to weight loss for restoring cartilage composition and function in obesity patients include: 1) Matrix-assisted autologous chondrocyte transplantation (MACT), which has shown potential in regenerating cartilage in osteoarthritic knees. 2) Lorecivivint, an intra-articular CLK2/DYRK1A inhibitor and Wnt pathway modulator, which has demonstrated efficacy in clinical trials for knee osteoarthritis. 3) Platelet-rich plasma (PRP) injections, which have been found to inhibit inflammatory processes in osteoarthritic chondrocytes. 4) Low-Intensity Pulsed Ultrasound (LIPUS), which has shown promise in pre-clinical and clinical studies for its effects on chondrocytes and cartilage.

← Back to Search

Other

Weight Loss for Knee Health in Obese Individuals (ROCCK Trial)

N/A

Waitlist Available

Led By Lou DeFrate

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if losing weight can improve knee joint health in obese individuals aged 18-45. Participants will follow a weight loss program to reduce stress on their knee joints, potentially restoring cartilage and improving function.

Who is the study for?

This trial is for adults aged 18-45 with obesity (BMI of 29 to less than 40) who do not have symptoms of knee osteoarthritis, no history of lower extremity injury, and can fit in an MRI machine. Pregnant individuals or those with metal implants are excluded.

What is being tested?

The study investigates if weight loss can restore cartilage composition and function in obese individuals. Participants will undergo MR Imaging, gait analysis for joint loading, cartilage strain measurement, and a weight loss program.

What are the potential side effects?

Potential side effects may include discomfort from MRI procedures or physical assessments. The weight loss intervention might cause fatigue, nutritional deficiencies if not monitored properly, muscle soreness, and psychological stress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cartilage

Secondary study objectives

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

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

Change from baseline in body weight at 3 and 6 months

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weight-LossExperimental Treatment1 Intervention

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.

Group II: Wellness EducationActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Weight Loss

2008

Completed Phase 3

~1570

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include lifestyle modifications, pharmacotherapy, and bariatric surgery. Lifestyle modifications, such as diet and exercise, aim to reduce caloric intake and increase energy expenditure, leading to weight loss and improved metabolic health. Pharmacotherapy options, like GLP-1 receptor agonists (e.g., semaglutide) and combination drugs (e.g., phentermine-topiramate), work by suppressing appetite, enhancing satiety, or reducing nutrient absorption. Bariatric surgery, including procedures like gastric bypass, physically restricts food intake and alters gut hormones to promote weight loss. These treatments are crucial for obesity patients as they not only help in reducing weight but also improve comorbid conditions like type 2 diabetes and osteoarthritis, potentially restoring cartilage composition and function.