Lifestyle Intervention for Diabetes

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 2 Jurisdictions

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.

Trial 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 (Behavioural 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Joslin Diabetes Center Boston, MA

Who Is Running the Clinical Trial?

Joslin Diabetes Center Lead Sponsor

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] Intensive lifestyle interventions (LI) improve outcomes in obesity and type 2 diabetes but are not currently available in usual care.

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

Effectiveness of a lifestyle intervention on metabolic syndrome. A randomized controlled trial. [2022] Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals.

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] The clinical effectiveness of intensive lifestyle interventions in preventing or delaying diabetes in people at high risk has been established from randomised trials of structured, intensive interventions conducted in several countries over the past two decades. The challenge is to translate them into routine clinical settings. The objective of this review is to determine whether lifestyle interventions delivered to high-risk adult patients in routine clinical care settings are feasible and effective in achieving reductions in risk factors for diabetes.

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] Lifestyle interventions improve the metabolic control of individuals with hyperglycemia.

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] Lifestyle behavior modification is an essential component of self-management of type 2 diabetes. We evaluated the prevalence of engagement in lifestyle behaviors for management of the disease, as well as the impact of healthcare professional support on these behaviors.

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] The majority of individuals with Type 2 diabetes (T2D) are overweight or obese, and this excess adiposity negatively impacts cardiovascular risk and contributes to challenges in disease management. Treatment of obesity by behavioral lifestyle intervention, within the context of diabetes, produces broad and clinically meaningful health improvements, and recent studies demonstrate long-term sustained weight management success with behavioral lifestyle interventions. Details of the Look AHEAD intensive lifestyle intervention are provided as an exemplar approach to the secondary prevention of T2D and obesity. The presence of behavior change expertise in the development and delivery of evidence-based behavioral weight control is discussed, and issues of adaptation and dissemination are raised, with a model to guide these important steps provided. (PsycINFO Database Record

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

Efficacy of lifestyle behavior change programs in diabetes. [2022] Evidence that a comprehensive lifestyle behavior change program targeting eating and physical activity, and ultimately weight loss, can alter the course of diabetes progression is growing. This report summarizes data from major clinical trials primarily, describes key features of behavior change programs, and comments on existing challenges regarding the adequacy, sustainability, and feasibility of behavior change programs for weight loss and diabetes prevention.

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

Lifestyle and the Prevention of Type 2 Diabetes: A Status Report. [2020] Diabetes is a costly disease affecting 387 million individuals globally and 28 million in the United States. Its precursor, prediabetes, affects 316 and 86 million individuals globally and in the United States, respectively. People living with elevated blood glucose levels are at high risk for all-cause mortality and numerous cardiometabolic ailments. Fortunately, diabetes can be prevented or delayed by maintaining a healthy lifestyle and a healthy body weight. In this review, we summarize the literature around lifestyle diabetes prevention programs and provide recommendations for introducing prevention strategies in clinical practice. Overall, evidence supports the efficacy and effectiveness of lifestyle diabetes prevention interventions across clinical and community settings, delivery formats (eg, individual-, group-, or technology-based), and implementers (eg, clinicians, community members). Evidence-based diabetes prevention strategies that can be implemented in clinical practice include brief behavior change counseling, group-based education, community referrals, and health information technologies. These strategies represent opportunities where practitioners, communities, and health care systems can work together to provide individuals with education, support and opportunities to maintain healthy, diabetes-free lifestyles.

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] Intensive lifestyle intervention (ILI) has significantly reduced incidence of diabetes and improved many cardiovascular disease risk factors. We evaluated long-term effects of ILI on cardiometabolic risk factors, and microvascular and macrovascular complications among patients with diabetes in real-world clinical practice.

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

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults: A Randomized Controlled Trial. [2023] Lifestyle intervention is recommended as first-line treatment of diabetes at all ages; however, little is known about the efficacy of lifestyle intervention in older adults with diabetes. We aimed to determine whether lifestyle intervention would improve glycemic control and age-relevant outcomes in older adults with diabetes and comorbidities.