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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a shift to a less active lifestyle with increased carbohydrate intake affects insulin resistance and metabolic processes in healthy individuals. It seeks to determine if such lifestyle changes hinder the body's ability to manage blood sugar and break down fats. The trial compares different groups: one with low activity and extra sugar intake (Obesogenic Lifestyle Group), another with low activity but no extra sugar, a third with high activity and extra sugar, and a normal activity control group (Sedentary Control). Ideal participants are young adults who exercise regularly and maintain good overall fitness. As an unphased trial, this study allows participants to contribute to foundational research that could enhance understanding of lifestyle impacts on health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changes in exercise and diet can affect how the body uses insulin, a hormone that controls blood sugar. One study found that insufficient exercise might impair insulin use by affecting pancreatic function. The pancreas releases insulin to manage blood sugar levels.

Another study found that regular exercise can enhance insulin use, reducing the risk of high blood sugar. High-intensity exercise, in particular, has been linked to improved insulin efficiency.

Regarding carbohydrate intake, results are mixed. Some individuals on low-carb diets have lower insulin levels, but the effects of varying carbohydrate intake with different exercise levels are still under investigation.

Overall, the treatments in this study emphasize lifestyle changes, which generally pose fewer risks than new medications. However, consulting a doctor before making significant changes to diet or exercise is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different lifestyle factors contribute to insulin resistance, a key player in conditions like type 2 diabetes. Unlike traditional treatments that focus on medication or diet changes alone, this trial examines the interplay between physical activity and sugar intake. By comparing groups with varying activity levels and sugar consumption, the study aims to uncover how these lifestyle modifications impact insulin sensitivity. This could pave the way for personalized lifestyle recommendations that are more effective than a one-size-fits-all approach.

What evidence suggests that this trial's treatments could be effective for insulin resistance?

This trial will compare different lifestyle interventions to assess their impact on insulin resistance. Research has shown that consuming sugary drinks and lacking exercise can increase the risk of metabolic syndrome, a group of conditions that raise the chances of heart disease, stroke, and diabetes. Studies also indicate that sugary drinks can lead to insulin resistance, a condition where the body doesn't respond well to insulin, the hormone that helps control blood sugar. However, regular exercise improves how the body uses insulin. High-intensity exercise is especially effective at improving insulin resistance compared to moderate, short-term exercise. These findings suggest that lifestyle choices, like diet and exercise, are important for managing insulin resistance and overall health. Participants in this trial will be assigned to different groups to evaluate these lifestyle factors, including varying levels of physical activity and sugar intake. ^{1 5 6 7 8}

Who Is on the Research Team?

Michael S Brian, PhD

Principal Investigator

University of New Hampshire

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910017/

Physical activity in metabolic syndrome - PMC High-intensity, long-term exercise had a better effect on improving indices related to insulin resistance in healthy individuals, while shorter, moderate- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569266/

Update on the effects of physical activity on insulin sensitivity ... Recent studies provide further evidence to support the notion that regular PA reduces the risk of insulin resistance, metabolic syndrome and type 2 diabetes.

3. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(24)00001-7/fulltext

Sugar-sweetened or artificially-sweetened beverage ... This study aimed to examine the independent and joint associations between SSB or ASB consumption and physical activity and risk of CVD, ...

4. mdpi.com mdpi.com/2411-5142/10/3/244

A Systematic Review with Meta-Analysis of Clinical Trials This purpose of this study was to analyze the effectiveness of changes in biochemical, physiological, and anthropometric indicators of MetS based on distinct ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0939475324003636

Sugar-sweetened beverages, low/no-calorie ... Sugar-sweetened beverages were associated with a higher risk of MetS. Fruit juice showed a J-shaped association with MetS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6908414/

Physical Activity/Exercise and Diabetes: A Position ... Moderate to high volumes of aerobic activity are associated with substantially lower cardiovascular and overall mortality risks in both type 1 and type 2 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01357382

The ACT-OUT Trial: ACTivity OUTcomes Based on High ... Failure of the eat less-exercise more strategy is evident with epidemic of obesity, metabolic syndrome (MetS) and type II diabetes. Moreover, ...

8. bmjopensem.bmj.com bmjopensem.bmj.com/content/2/1/e000143

Update on the effects of physical activity on insulin ... Discussion and conclusions Recent studies provide further evidence to support the notion that regular PA reduces the risk of insulin resistance ...