What side effects are associated with this type of intervention?

Common treatments for obesity include pharmacological agents like GLP-1 receptor agonists (liraglutide, semaglutide), which can cause gastrointestinal side effects such as nausea and vomiting. SSRIs, used for their appetite-suppressing effects, may lead to side effects like insomnia, sexual dysfunction, and weight gain. Other anti-obesity medications, such as orlistat, can cause gastrointestinal issues like oily stools and flatulence. Lifestyle interventions, including diet and exercise, generally have fewer side effects but may lead to temporary discomfort or injury if not properly managed.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity that target appetite regulation and metabolic processes. Notable among these are glucagon-like peptide-1 (GLP-1) receptor agonists such as liraglutide, which has shown efficacy in weight loss and glycemic control. Another approved combination is phentermine-topiramate, which has demonstrated significant weight loss in clinical trials. These treatments align with the study of biological responses to overeating by influencing appetite and energy expenditure.

What other types of research exist?

Promising novel alternatives for obesity treatment in 2024 include: 1) Ghrelin receptor antagonists, which block orexigenic signals and may be effective anti-obesity therapies. 2) GLP-1 agonists like liraglutide and extended-release exenatide, which promote weight loss and improve glycemic control. 3) Peptide-conjugate therapies targeting key metabolic tissues, which are close to market. 4) Oral delivery methods for peptide gut hormones, expanding treatment accessibility. These approaches are based on recent advancements and ongoing clinical trials.

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Diet and Exercise Responses in Obesity (ARrOW Trial)

N/A

Recruiting

Led By Daniel Bessesen, MD

Research Sponsored by University of Colorado, Denver

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 30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how overeating affects appetite, energy use, physical activity, and fat burning in obese individuals and those who have lost weight. It aims to understand why some people regain weight after losing it and how to prevent this.

Who is the study for?

This trial is for adults with obesity (BMI of 30-38) who are either content with their weight or want to lose weight, do minimal exercise, and have a stable sleep schedule. They must live near CU-AMC, own a smartphone, and women must use contraception if needed. People can't join if they've had weight loss surgery, abnormal diets, certain diseases including HIV/hepatitis B/C or psychiatric conditions, work night shifts or take medications affecting weight.

What is being tested?

The study looks at how obese individuals respond biologically after losing weight through diet alone or diet plus exercise. It examines appetite control, energy usage during rest and activity levels following brief periods of overeating to understand factors that may prevent or contribute to regaining lost weight.

What are the potential side effects?

Since the interventions include lifestyle changes like overfeeding and exercise training rather than medication, side effects might include discomfort from excess eating or muscle soreness from new physical activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fat oxidation as a correlate of weight regain as measured by room calorimetry

Secondary study objectives

24h hormone and metabolite profiles as a correlate of weight regain as measured by assay of plasma samples

Body Composition via DXA

Body weight per scale

+13 more

Other study objectives

Change in fitness as measured by indirect calorimetry

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Reduced obese + diet + exerciseExperimental Treatment3 Interventions

Persons with obesity randomized to a weight loss program consisting of caloric restriction, behavioral support, and supervised endurance exercise training. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

Group II: ControlActive Control1 Intervention

Persons with obesity who do not undergo weight loss will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

Group III: Reduced obese + diet groupActive Control2 Interventions

Persons with obesity randomized to a weight loss program consisting of caloric restriction and behavioral support. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

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 dietary therapy, pharmacologic therapy, and behavioral interventions. Dietary therapy focuses on reducing caloric intake and altering macronutrient composition to promote weight loss. Pharmacologic treatments, such as GLP-1 receptor agonists like liraglutide and semaglutide, work by enhancing satiety and reducing appetite, thereby decreasing caloric intake. Behavioral interventions aim to modify eating habits and increase physical activity through cognitive-behavioral strategies. Understanding these mechanisms is crucial for obesity patients as they address the biological responses to overeating, such as changes in appetite, energy expenditure, and fat metabolism, which are key factors in managing and preventing weight regain.

Weight loss in neurodegenerative disorders.