Lifestyle Intervention for Diabetes

Overseen By Elvira Isganaitis, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Joslin Diabetes Center

Must not be taking: Nitrates, Steroid hormones

Disqualifiers: Chronic kidney disease, Hepatic disease, Severe retinopathy, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to evaluate whether epigenetic markers in overweight men with type 1 diabetes (T1D) or type 2 diabetes (T2D) can be improved with a 3 month lifestyle intervention or program focused in glycemic intervention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using nitrates, guanylate cyclase stimulators, and steroid hormones (except inhalers for reactive airway disease).

What data supports the effectiveness of the treatment Lifestyle Intervention for Diabetes?

Research shows that intensive lifestyle interventions, which include changes in diet and physical activity, can significantly reduce the risk of developing diabetes in high-risk individuals and improve outcomes for those with type 2 diabetes. ^{1 2 3 4 5}

Is lifestyle intervention safe for humans?

Lifestyle interventions, which include changes in diet and physical activity, have been shown to be safe for humans and are used to manage conditions like obesity and Type 2 diabetes. These interventions are generally well-tolerated and focus on promoting healthy habits without significant safety concerns. ^{1 3 6 7 8}

How is the Lifestyle Intervention treatment for diabetes different from other treatments?

The Lifestyle Intervention treatment for diabetes is unique because it focuses on changing daily habits through diet, exercise, and behavior changes, rather than relying on medication. This approach can improve diabetes management and prevent complications by addressing the root causes of the condition, such as obesity and inactivity, which are not typically targeted by standard drug treatments. ^{1 3 8 9 10}

Eligibility Criteria

Men aged 18-65 with type 1 or type 2 diabetes, overweight (BMI >25), and an HbA1c level over 7% can join this study. They must be able to follow the study plan and provide sperm samples. Men with severe diabetic eye disease, recent heart issues, cancer treatments within five years, certain hormone disorders, smoking habits, serious infections or organ failures are not eligible.

Inclusion Criteria

Willing and able to provide informed consent and follow all study procedures, including providing sperm specimens 3 months apart

You weigh more than what is considered healthy for your height.

I am a man aged between 18 and 65.

Exclusion Criteria

You smoke cigarettes.

I am currently using nitrates or guanylate cyclase stimulators.

You are currently misusing alcohol or drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

20 overweight men with T1D or T2D undergo a 3-month lifestyle intervention program aimed at improving metabolic health, glycemic control, and body weight

12 weeks

Regular visits for intervention monitoring

No-Intervention Control

10 overweight men with T1D or T2D and 10 healthy men are assessed at baseline and at 3 months without participating in a lifestyle intervention

12 weeks

2 visits (baseline and 3 months)

Follow-up

Participants are monitored for changes in sperm epigenetic marks and metabolic health outcomes

1 year

Treatment Details

Interventions

• Lifestyle Intervention

Trial Overview The trial is testing if a lifestyle program focused on managing blood sugar levels can improve epigenetic markers in sperm of overweight men with diabetes. Participants will either receive this intervention or no intervention for comparison over three months.

Participant Groups

Group I: Lifestyle Intervention Experimental Treatment 1 Intervention

20 overweight men with T1D or T2D will undergo an intensive 3 month lifestyle intervention program aimed at improving metabolic health, glycemic control, and body weight.

Group II: No-Intervention Controls Active Control 1 Intervention

10 overweight men with T1D or T2D will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.

Group III: Healthy Controls Active Control 1 Intervention

10 healthy men will be assessed at baseline and at 3 months. They will not participate in a lifestyle intervention.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

Findings from Research

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 1-year lifestyle intervention program significantly reduced metabolic syndrome and related health issues in a group of 335 adults aged 45-64, demonstrating its effectiveness compared to standard care from family physicians.

The intervention led to a 31% absolute risk reduction in metabolic syndrome and decreased rates of central obesity and hypertriglyceridemia, highlighting its potential to prevent diabetes and improve overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a lifestyle intervention on metabolic syndrome. A randomized controlled trial. Bo, S., Ciccone, G., Baldi, C., et al.[2022]

Lifestyle interventions aimed at reducing diabetes risk in high-risk adults are feasible to implement in routine clinical settings, as supported by various healthcare providers.

While these interventions led to significant weight and waist circumference reductions after one year, they showed limited clinical benefits in improving biochemical markers or diabetes incidence, suggesting that translating intensive trial results into everyday practice may not yield the same effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of diabetes risk in routine clinical practice: are physical activity and nutrition interventions feasible and are the outcomes from reference trials replicable? A systematic review and meta-analysis. Cardona-Morrell, M., Rychetnik, L., Morrell, SL., et al.[2022]

A systematic review of 11 randomized clinical trials involving individuals with prediabetes and type 2 diabetes found that intensive lifestyle interventions did not significantly reduce cardiovascular or all-cause mortality compared to usual care.

The analysis showed no differences in outcomes based on the type of intervention or other factors, indicating that current lifestyle interventions may not provide additional mortality benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effect of Lifestyle Interventions on the Cardiovascular and All-Cause Mortality of Subjects With Prediabetes and Type 2 Diabetes: A Systematic Review and Meta-analysis. Zucatti, KP., Teixeira, PP., Wayerbacher, LF., et al.[2023]

A large survey of 2682 adults with type 2 diabetes revealed that while most participants reported engaging in dietary changes (89.7%) and weight control (72.1%), only 30.6% successfully quit smoking, highlighting varying levels of engagement in self-management behaviors.

Patients who did not receive advice from healthcare professionals were significantly less likely to engage in dietary changes, exercise, or weight control, indicating that professional support is crucial for effective self-management of diabetes, especially for those living with the condition for over six years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of lifestyle behavior in type 2 diabetes: results of the 2011 cross-sectional survey on living with chronic diseases in Canada. Agborsangaya, CB., Gee, ME., Johnson, ST., et al.[2023]

Behavioral lifestyle interventions for obesity in individuals with Type 2 diabetes have shown significant and lasting health improvements, highlighting their importance in disease management.

The Look AHEAD intensive lifestyle intervention serves as a successful model for secondary prevention of Type 2 diabetes and obesity, emphasizing the need for behavior change expertise in developing effective weight control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based lifestyle interventions for obesity and Type 2 diabetes: The Look AHEAD intensive lifestyle intervention as exemplar. West, DS., Coulon, SM., Monroe, CM., et al.[2022]

Comprehensive lifestyle behavior change programs that focus on diet and physical activity have shown promise in altering the progression of diabetes, highlighting their potential efficacy in weight loss and diabetes management.

The report discusses challenges related to the sustainability and feasibility of these programs, indicating that while they can be effective, maintaining long-term behavior change remains a significant hurdle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of lifestyle behavior change programs in diabetes. Venditti, EM.[2022]

Diabetes affects 387 million people worldwide, with prediabetes impacting an additional 316 million, highlighting the urgent need for effective prevention strategies.

Lifestyle diabetes prevention programs have been shown to be effective in various settings and formats, including individual counseling and group education, providing practical recommendations for healthcare practitioners to help individuals maintain healthy lifestyles and prevent diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle and the Prevention of Type 2 Diabetes: A Status Report. Galaviz, KI., Narayan, KMV., Lobelo, F., et al.[2020]

In a study of 129 patients with diabetes and obesity, those who maintained a weight loss of 7% or more over one year showed significantly better long-term blood sugar control (A1c levels) and a 68% lower risk of developing nephropathy over 10 years compared to those who lost less weight.

The average weight loss of participants was 10.8 kg after 12 weeks, and they maintained an average of 7.7 kg loss over 10 years, demonstrating that intensive lifestyle intervention can lead to sustained weight management and improved cardiometabolic health in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effect of intensive lifestyle intervention on cardiometabolic risk factors and microvascular complications in patients with diabetes in real-world clinical practice: a 10-year longitudinal study. Tomah, S., Zhang, H., Al-Badri, M., et al.[2023]

A 1-year intensive lifestyle intervention (ILI) significantly improved glycemic control in older adults with diabetes, reducing HbA1c levels by an average of -0.8%, compared to only a 0.1% increase in the healthy lifestyle (HL) group.

The ILI also led to notable improvements in physical health, including increased insulin sensitivity, reduced body weight, and enhanced physical performance, while decreasing the total insulin dose needed, although it was associated with more mild hypoglycemia episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults: A Randomized Controlled Trial. Celli, A., Barnouin, Y., Jiang, B., et al.[2023]

References

1. 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]

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

Effectiveness of a lifestyle intervention on metabolic syndrome. A randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Reduction of diabetes risk in routine clinical practice: are physical activity and nutrition interventions feasible and are the outcomes from reference trials replicable? A systematic review and meta-analysis. [2022]

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

Long-term Effect of Lifestyle Interventions on the Cardiovascular and All-Cause Mortality of Subjects With Prediabetes and Type 2 Diabetes: A Systematic Review and Meta-analysis. [2023]

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

Determinants of lifestyle behavior in type 2 diabetes: results of the 2011 cross-sectional survey on living with chronic diseases in Canada. [2023]

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

Evidence-based lifestyle interventions for obesity and Type 2 diabetes: The Look AHEAD intensive lifestyle intervention as exemplar. [2022]

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

Efficacy of lifestyle behavior change programs in diabetes. [2022]

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

Lifestyle and the Prevention of Type 2 Diabetes: A Status Report. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Long-term effect of intensive lifestyle intervention on cardiometabolic risk factors and microvascular complications in patients with diabetes in real-world clinical practice: a 10-year longitudinal study. [2023]

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

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults: A Randomized Controlled Trial. [2023]