Mindfulness Meditation for Type 2 Diabetes

(E-RCT Trial)

Overseen By Alana Biggers, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Untreated sleep apnea, Severe insomnia, Cognitive impairments, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness meditation can help African-American adults with type 2 diabetes improve sleep and reduce stress. By focusing on these areas, the researchers aim to determine if this practice might lower the risk of heart disease in high-risk individuals. Participants will attend eight mindfulness classes, either in-person or online, and receive text message reminders to practice at home. The trial seeks African-American adults with type 2 diabetes living in the Chicagoland area who have a mobile device and are not already practicing mindfulness.

As an unphased trial, this study offers a unique opportunity to explore the benefits of mindfulness on health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that mindfulness meditation is safe for African-American adults with type 2 diabetes?

Research has shown that mindfulness meditation is generally safe for most people, including those with type 2 diabetes. Studies have found that mindfulness practices can improve overall health without causing serious side effects. These practices often help reduce stress and boost mental well-being, which can aid in managing diabetes.

In previous studies, participants who practiced mindfulness reported feeling less stressed and more in control of their symptoms. While mindfulness usually doesn't cause harmful effects, individual experiences can vary. Those considering joining a mindfulness meditation trial should consult their doctor to determine if it's suitable for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness Meditation is unique because it introduces a non-pharmaceutical approach to managing Type 2 Diabetes, focusing on mental and physical well-being. Unlike traditional treatments that primarily involve medication like Metformin or insulin to control blood sugar levels, this method emphasizes stress reduction and lifestyle change through guided meditation sessions. Researchers are excited about this approach because it offers a holistic alternative that could improve patients' overall quality of life, potentially reducing reliance on medication and enhancing mental health.

What evidence suggests that mindfulness meditation is effective for improving sleep and reducing stress in African-American adults with type 2 diabetes?

Research has shown that mindfulness meditation, which participants in this trial may receive, can benefit people with type 2 diabetes. Studies have found that practicing mindfulness reduces stress, improves blood sugar levels, and lowers HbA1c, a measure of blood sugar control. Additionally, mindfulness enhances mental well-being and reduces anxiety, aiding in better diabetes management. This practice might also decrease the risk of heart disease for those with type 2 diabetes. Therefore, mindfulness meditation could improve both physical and mental health for people with diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Alana Biggers

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for African-American adults aged 21-75 with type 2 diabetes living in the greater Chicagoland area. Participants must have a mobile device with internet and be able to text. They can't join if they already practice mindfulness, have severe sleep disorders, major cognitive or psychiatric issues, substance abuse problems, or untreated obstructive sleep apnea.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

Mobile device (smartphone, tablet, or computer) with the ability to connect to the internet if remote online delivery

You have a mobile phone with unlimited text messaging.

Exclusion Criteria

I regularly practice mindfulness.

I have severe insomnia, narcolepsy, or a REM sleep disorder.

You have a history of alcohol or drug abuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 8 two-hour mindfulness meditation classes over 8 weeks, with text messaging support between classes

8 weeks

8 visits (in-person or online)

Follow-up

Participants are monitored for sleep quality, perceived stress, and cardiometabolic risk factors after treatment

8 weeks

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Meditation

Trial Overview The study tests a mindfulness meditation program aimed at improving sleep and reducing stress in African-Americans with type 2 diabetes. The goal is to see if this program can lower their risk of cardiovascular disease.

How Is the Trial Designed?

Group I: Mindfulness Meditation Classes Experimental Treatment 1 Intervention

8 mindfulness classes: Participants will engage in 8 two-hour mind and body practice classes over 8 weeks in-person or online (during the pandemic). You will receive compensation for your participation and a yoga mat. You will need to wear comfortable clothing. These sessions can be done sitting in chair, sitting on the floor, or standing. Text messaging., in between classes you will receive text messages to encourage mind and body practices at home. Text messaging may appear as the following: 1.Do you have time to meditate right now? Yes or No. 2.Did you practice your mindfulness today? Yes or no. 3.Remember to wind down this evening and do not drink any caffeinated beverages 4 hours before bed.

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Meditation-based strategies can significantly reduce psychological distress in individuals with diabetes, leading to improvements in stress levels, emotional wellbeing, and coping skills.

Mindfulness meditation has shown modest benefits in managing diabetes-related health outcomes, such as body weight, glycaemic control, and blood pressure, making it a valuable complementary approach alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-Body Interactions and Mindfulness Meditation in Diabetes. Priya, G., Kalra, S.[2022]

In a study with 38 participants, mindfulness-based stress reduction (MBSR) significantly decreased diabetes-related distress and improved glucose control, indicating its potential as an effective intervention for diabetes management.

Participants also experienced notable improvements in mental health factors such as depression, anxiety, and self-efficacy, suggesting that MBSR can enhance both diabetes management and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing diabetes distress and improving self-management with mindfulness. Whitebird, RR., Kreitzer, MJ., Vazquez-Benitez, G., et al.[2022]

A 4-week guided meditation program, Cyclic Meditation, significantly improved quality of life and sleep in 30 patients with type 2 diabetes, with quality of life scores increasing by 7.1% and sleep scores by 32.7%.

The meditation practice also led to substantial reductions in perceived stress (26.1%), anxiety (16.01%), and depression (37.63%), highlighting its effectiveness as a complementary approach to traditional medical management for T2DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between a guided meditation practice, sleep and psychological well-being in type 2 diabetes mellitus patients. Varghese, MP., Balakrishnan, R., Pailoor, S.[2021]

Mindfulness-based stress reduction (MBSR) significantly improves mental health outcomes, such as reducing anxiety and depressive symptoms, and enhances mindfulness in diabetes patients, based on a systematic review of 10 studies with 718 participants.

While MBSR showed positive effects on mental health, it did not have a significant impact on lowering HbA1C levels, indicating that while it benefits psychological well-being, it may not directly influence blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based stress reduction (MBSR) on the mental health, HbA1C, and mindfulness of diabetes patients: A systematic review and meta-analysis of randomised controlled trials. Fisher, V., Li, WW., Malabu, U.[2023]

In a study involving 60 patients with type 2 diabetes, an 8-session mindfulness-based stress reduction (MBSR) program significantly improved emotional well-being and glycemic control, as evidenced by reductions in fasting blood sugar (FBS) and HbA1c levels.

The MBSR intervention also led to significant decreases in anxiety and depression scores compared to the control group, highlighting its potential as an effective complementary treatment for managing both emotional and physical health in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Mindfulness-Based Stress Reduction on Emotional Wellbeing and Glycemic Control of Patients with Type 2 Diabetes Mellitus. Armani Kian, A., Vahdani, B., Noorbala, AA., et al.[2022]

A six-week mindfulness and meditation intervention was piloted with 40 participants who had diabetes or coronary heart disease, showing high acceptability with 90% completing at least 5 sessions.

The intervention significantly reduced worry and thought suppression, suggesting that mindfulness can improve psychological health by helping individuals develop better coping skills related to their illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-methods pilot study of the acceptability and effectiveness of a brief meditation and mindfulness intervention for people with diabetes and coronary heart disease. Keyworth, C., Knopp, J., Roughley, K., et al.[2022]

In a study of 666 participants with diabetes, certain mindfulness traits (like acting with awareness and non-judging) were found to significantly reduce symptoms of anxiety and depression, indicating that mindfulness can be beneficial for emotional well-being in diabetic individuals.

Mindfulness also appeared to help buffer the negative effects of stressful life events on emotional distress, suggesting it could be a protective factor, although it did not significantly moderate the impact of comorbid health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between mindfulness and emotional distress in adults with diabetes: could mindfulness serve as a buffer? Results from Diabetes MILES: The Netherlands. van Son, J., Nyklíček, I., Nefs, G., et al.[2022]

In a study of 56 adults with diabetes, no significant differences were found in stress response, glycemic control, or vascular inflammation among those participating in Korean mindfulness-based stress reduction (K-MBSR), walking, or patient education.

However, both the K-MBSR and walking groups showed significant reductions in serum cortisol and PAI-1 levels, indicating potential benefits in stress hormone regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of Korean mindfulness-based stress reduction, walking, and patient education in diabetes mellitus. Jung, HY., Lee, H., Park, J.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084514/

Mindfulness-based interventions for adults with type 2 ... Mindfulness-based interventions (MBIs) may improve metabolic and psychological health in individuals with T2DM.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2909138/

Mindfulness-Based Stress Reduction and Diabetes - PMC This review highlights the literature and research on Mindfulness-Based Stress Reduction to improve the health and well-being of individuals with diabetes.

3. diabetesjournals.org diabetesjournals.org/spectrum/article-split/38/3/307/160543/Meta-Analytic-Insights-Into-Mindfulness-Approaches

Meta-Analytic Insights Into Mindfulness Approaches for ... Studies have shown that mindfulness practices reduce physiological stress responses, alleviate anxiety, and improve A1C and fasting blood ...

4. mdpi.com mdpi.com/2227-9032/12/18/1876

Effectiveness of Mindfulness-Based Interventions with ... Effectiveness of mindfulness-based interventions with respect to psychological and biomedical outcomes in young people with type 1 diabetes.

5. medrxiv.org medrxiv.org/content/10.1101/2023.12.27.23300572v1.full-text

The Effect of Mindfulness Based Stress Reduction on ... Mindfulness has a significant effect on reducing fasting blood sugar levels and HbA1c in type 2 DM patients.

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06771-2

Effects of meditation on physiological and metabolic ... This study aims to identify the effect of mindfulness meditation on glycaemic control and the possible mechanisms (neuro humoral and autonomic functions)

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213422025000186

Mindfulness-based interventions for adults with type 2 ... Mindfulness-based interventions (MBIs) may improve metabolic and psychological health in individuals with T2DM.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05195138

Mindfulness-Based Diabetes Education for Adults With ... The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management ...

9. mdpi.com mdpi.com/2305-6320/10/9/53

The Effects of Mindfulness on Glycemic Control in People ... Mindfulness interventions show potential for improving glycemic control as measured by hemoglobin A1c (HbA1c) levels, as well as reducing stress, depression, ...