What side effects are associated with this type of intervention?

Supervised aerobic training and yoga are generally safe and well-tolerated forms of exercise. Common side effects of aerobic training may include muscle soreness, fatigue, and, in rare cases, overuse injuries such as tendinitis. Yoga is also typically safe, with potential side effects including muscle strain or soreness, particularly in beginners or those with pre-existing conditions. Both forms of exercise can improve insulin sensitivity by altering fat and sugar metabolism, contributing to better overall metabolic health.

What prior FDA approvals exist?

There are no specific FDA-approved drugs exclusively for 'Lean Trained Subjects' focusing on supervised aerobic or yoga training. However, exercise interventions, including aerobic and resistance training, have been shown to improve insulin sensitivity and metabolic health. These benefits are well-documented in various populations, including those with type 2 diabetes and obesity. Such exercise regimens can alter fat and sugar metabolism, contributing to better overall metabolic profiles.

What other types of research exist?

Promising novel alternatives to supervised aerobic or yoga training for improving insulin sensitivity in lean trained subjects include high-intensity interval training (HIIT), resistance training, and combined exercise modalities. HIIT has been shown to improve insulin sensitivity through short bursts of intense exercise followed by rest periods. Resistance training, involving weight lifting or bodyweight exercises, can enhance muscle mass and improve glucose metabolism. Additionally, combining aerobic and resistance training may offer synergistic benefits for metabolic health.

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Yoga vs Running for Metabolic Health (TrainMeUpMN Trial)

Q: What is the mechanism of action of this treatment?

Supervised aerobic and yoga training improve insulin sensitivity in lean trained subjects by enhancing the body's ability to utilize fat and sugar. This is achieved through increased mitochondrial activity and changes in muscle composition, which facilitate better glucose uptake and utilization. These mechanisms are crucial for maintaining metabolic health and preventing insulin resistance, a precursor to type 2 diabetes.

N/A

Waitlist Available

Led By Lisa S. Chow, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

For overweight or obese subjects: Insulin resistant based on screening oral glucose tolerance testing, BMI 25 to 40 kg/m2 inclusive, stable weight for at least 3 months (± 5 lbs.), sedentary status (self-report < 30 minutes/week regular exercise)

All subjects must be 18 to 40 years of age and capable of giving informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how different types of exercise affect the body's ability to handle sugar in people with different body types.

Who is the study for?

This trial is for people aged 18-40, with a BMI of 25 to 40 kg/m2. It's open to those who are overweight or obese and insulin resistant but generally healthy. Participants should be sedentary (exercising less than 30 minutes per week) or lean and physically active (3-5 aerobic sessions per week), with stable weight for the past three months.

What is being tested?

The study compares fat and sugar metabolism in individuals before and after they complete either a supervised treadmill running program or a yoga training program. The goal is to understand how these activities affect insulin resistance, which can lead to type 2 diabetes.

What are the potential side effects?

While not explicitly listed, potential side effects may include typical exercise-related risks such as muscle strain, fatigue, joint pain from the running program; yoga might cause muscle soreness or stretching-related injuries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am overweight or obese, have insulin resistance, a stable weight, and exercise less than 30 minutes a week.

Select...

I am between 18 and 40 years old and can make my own medical decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Differences in insulin sensitivity between groups

Secondary study objectives

Differences in fitness level between groups

Other study objectives

Differences in body composition between groups

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: Obese or OverweightExperimental Treatment2 Interventions

Running Program Yoga Program

Group II: Lean TrainedActive Control1 Intervention

Metabolic control

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Yoga Program

2022

N/A

~120

0 / 2Eligibility criteria met

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

Supervised aerobic and yoga training improve insulin sensitivity in lean trained subjects by enhancing the body's ability to utilize fat and sugar. This is achieved through increased mitochondrial activity and changes in muscle composition, which facilitate better glucose uptake and utilization. These mechanisms are crucial for maintaining metabolic health and preventing insulin resistance, a precursor to type 2 diabetes.

Exercise training improves mitochondrial respiration and is associated with an altered intramuscular phospholipid signature in women with obesity.Effects of Polarized Training on Cardiometabolic Risk Factors in Young Overweight and Obese Women: A Randomized-Controlled Trial.