Obesogenic Lifestyle for Insulin Resistance

Overseen By Michael Brian, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of New Hampshire

Disqualifiers: Hypertension, Diabetes, Cardiovascular disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial aims to learn about the alterations in insulin resistance and metabolic flexibility following a transition to an obesogenic lifestyle in fit young men and women. The main questions it aims to answer are: 1. Does adding excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance and impaired 24hr glucose regulation in healthy men and women? 2. Does adding excess carbohydrates when transitioning to a sedentary lifestyle lower the body's ability to break down fats and carbohydrates in healthy men and women? 3. Does the added physical activity blunt shifts in carbohydrate and fat oxidation in healthy men and women?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any of the listed health conditions, you may not be eligible to participate.

What data supports the effectiveness of the treatment Obesogenic Lifestyle Group, Sedentary Control for insulin resistance?

Research shows that intensive lifestyle interventions can lead to weight loss and improve outcomes in obesity and type 2 diabetes, which are related to insulin resistance. These interventions often include increased physical activity and dietary changes, which can help manage insulin levels and improve overall health. ^{1 2 3 4 5}

How does the Obesogenic Lifestyle Group treatment differ from other treatments for insulin resistance?

The Obesogenic Lifestyle Group treatment is unique because it focuses on lifestyle changes, such as diet and physical activity, to manage insulin resistance, rather than relying on medication. This approach aims to prevent further weight gain and improve insulin sensitivity by altering dietary fat intake and promoting an environment that supports healthy choices. ^{1 3 6 7 8}

Research Team

Michael S Brian, PhD

Principal Investigator

University of New Hampshire

Eligibility Criteria

This trial is for fit young men aged 18-26 who exercise moderately to vigorously at least two days a week. They should have good cardio fitness but can't join if they have diabetes, high fasting blood sugar, high blood pressure, heart disease, cancer, chronic kidney disease or any musculoskeletal issues that stop them from biking.

Inclusion Criteria

Men between the ages of 18 and 26.

You have good heart and lung fitness (VO2>38.6 ml/kg/min).

You exercise for 75-150 minutes at a moderate to vigorous level for at least 2 days a week.

Exclusion Criteria

You have been told by a doctor that you have diabetes.

Your blood sugar levels when you haven't eaten are higher than 100mg/dL.

You have a known heart or blood vessel condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-day intervention with varying levels of physical activity and carbohydrate intake

10 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Obesogenic Lifestyle Group
• Sedentary Control

Trial Overview The study looks at how an obesogenic lifestyle with extra carbs affects insulin resistance and the body's ability to use fats and carbs in active young men. Participants will be split into two groups: one adopting this new lifestyle and the other remaining sedentary as a control.

Participant Groups

Group I: Low Physical Activity and Added Carbohydrate Group Experimental Treatment 1 Intervention

10-days of low physical activity (\~5,000 steps/day) while consuming added sugar-sweetened beverages (\~180 g/day).

Group II: High Physical Activity and Added Carbohydrate Group Experimental Treatment 1 Intervention

10-days of high physical activity (\~11,000 steps/day) while consuming added sugar-sweetened beverages (\~180 g/day).

Group III: Normal Activity Control Active Control 1 Intervention

Maintains normal physical activity levels and exercise training

Group IV: Low Physical Activity Control Placebo Group 1 Intervention

10-days of sedentary activity (\~5,000 steps/day).

Who Is Running the Clinical Trial?

University of New Hampshire

Lead Sponsor

Trials

16

Recruited

105,000+

Findings from Research

In a 12-month study involving obese men, treatment with diazoxide (DZX) led to a significant reduction in fat mass, with an average decline of 15.7 kg by the end of the study, indicating its efficacy in promoting weight loss.

DZX treatment also resulted in notable improvements in cardiovascular health, including reductions in blood pressure and harmful cholesterol levels, although it was associated with a slight increase in fasting glucose and hemoglobin A1c.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. Loves, S., van Groningen, L., Filius, M., et al.[2019]

Both in-person and telephone group lifestyle interventions (LI) led to significantly greater weight loss compared to medical nutrition therapy (MNT) in patients with type 2 diabetes, with mean weight loss of 5.6% and 4.6% respectively at 6 months.

The cost-effectiveness of in-person LI was better than telephone LI, with an incremental cost of $789 per kilogram lost compared to $1223 for telephone LI, indicating that in-person programs may provide a more economical option for achieving weight loss in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. Delahanty, LM., Levy, DE., Chang, Y., et al.[2022]

A randomized clinical trial involving 445 participants showed that individual telephone counseling for obesity management significantly reduced weight regain compared to an email education control, with a posterior probability greater than 99%.

Participants receiving individual telephone counseling were more likely to achieve at least a 10% weight reduction (31.5%) compared to those in the control group (19.1%), indicating that personalized support can enhance long-term weight loss maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. Perri, MG., Shankar, MN., Daniels, MJ., et al.[2020]

The Intensive Lifestyle Intervention (ILI) led to a significant weight loss of 7.19 kg at 12 months compared to usual care (UC) in a study involving 803 underserved patients with obesity, indicating its efficacy in promoting weight loss.

Several factors, including improvements in eating behaviors and physical activity, partially explained the weight loss during the ILI, but the ILI group experienced some weight regain by month 24, suggesting the need for ongoing support to maintain weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial. Dorling, JL., Martin, CK., Yu, Q., et al.[2023]

A 10-14 week inpatient intensive lifestyle intervention (ILI) for 100 severely obese individuals led to significant improvements in quality of life, including reductions in binge eating, anxiety, and depression, as well as enhancements in physical and mental health.

The study found that improvements in binge eating and physical health were directly associated with weight loss, indicating that the ILI not only helped participants lose weight but also positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Danielsen, KK., Sundgot-Borgen, J., Mæhlum, S., et al.[2015]

Diet-related changes, such as reducing visceral fat and altering dietary fat composition, may enhance insulin sensitivity, but no long-term clinical trials have definitively proven that these measures can prevent type 2 diabetes.

While weight loss efforts in adults have been largely unsuccessful, focusing on preventing further weight gain and promoting healthier dietary fat choices could be more effective strategies for reducing insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can dietary intervention produce long-term reduction in insulin resistance? Mann, JI.[2019]

In a study of 531 native Asian Indians with impaired glucose tolerance (IGT), both lifestyle modification (LSM) and metformin (MET) significantly reduced the progression to type 2 diabetes, with a median follow-up of 30 months.

The relative risk reduction for developing diabetes was 28.5% with LSM and 26.4% with MET, indicating both interventions are effective, but combining them did not provide additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Ramachandran, A., Snehalatha, C., Mary, S., et al.[2022]

Insulin resistance syndrome, affecting 1 in 3 to 4 adults over 20, is a serious condition that increases the risk of type 2 diabetes and cardiovascular disease due to metabolic abnormalities like high triglycerides and hypertension.

Key lifestyle interventions, particularly weight loss and physical activity, are essential for managing this syndrome, highlighting the important role of nurses in monitoring patient outcomes and guiding future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin resistance syndrome. Fletcher, B., Lamendola, C.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Can dietary intervention produce long-term reduction in insulin resistance? [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Insulin resistance syndrome. [2019]