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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older
Be older than 18 years old
Must not have
Serious comorbid condition (such as uncontrolled hypertension, glaucoma, heart failure)
Extremely obese (i.e. Body Mass Index > 45 kg/m2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial involves adults with type-2 diabetes participating in either Iyengar yoga or a standard exercise program for a few months. The goal is to see if these activities can help manage diabetes and to understand how well people stick to these routines over time. The study will also check if these programs are practical and acceptable for people from different racial and ethnic backgrounds. Iyengar yoga has been studied as a complementary therapy for type-2 diabetes, showing promise in improving glycemic control and overall wellbeing.
Who is the study for?
Adults over 18 with type-2 diabetes who are stable on medications can join this study. It's not for those currently practicing yoga or similar activities, pregnant individuals, people unable to read/write English, extremely obese persons (BMI > 45), or those with serious health issues like uncontrolled hypertension or complications from diabetes.
What is being tested?
The trial is testing the effectiveness of a 12-week Iyengar yoga program compared to a standard exercise regimen in managing type-2 diabetes. Participants will be randomly assigned to one of these two groups and followed up at 3 and 6 months post-intervention.
What are the potential side effects?
Yoga may cause muscle soreness or strain if not practiced correctly. Standard exercises could also lead to similar physical strains. Nutrition counseling should have minimal side effects but might require dietary changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious health conditions like uncontrolled high blood pressure, glaucoma, or heart failure.
Select...
My BMI is over 45.
Select...
I have complications from diabetes like eye, nerve, or kidney problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability as indicated by participant satisfaction ratings
Feasibility assessed as session attendance
Secondary study objectives
Body Mass Index
Diabetes Distress as measured by the Problem Areas in Diabetes Scale
Fasting Blood Glucose
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: YogaExperimental Treatment2 Interventions
12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga
Group II: Standard ExerciseActive Control2 Interventions
12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutrition Counseling
2015
Completed Phase 2
~320
Iyengar yoga
2010
N/A
~70
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 2 Diabetes, such as physical activity and stress reduction, work by improving insulin sensitivity and lowering blood sugar levels. Physical activity helps cells use glucose more effectively and aids in weight management, reducing insulin resistance.
Stress reduction techniques, like yoga, lower cortisol levels, which can prevent blood sugar spikes. These mechanisms are essential for managing Type 2 Diabetes as they target the underlying issues of insulin resistance and high blood sugar, thereby enhancing overall metabolic health.
Development of a Yoga Program for Type-2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India.Metabolic effects of interventions to increase exercise in adults with type 2 diabetes.
Development of a Yoga Program for Type-2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India.Metabolic effects of interventions to increase exercise in adults with type 2 diabetes.
Find a Location
Who is running the clinical trial?
The Miriam HospitalLead Sponsor
244 Previous Clinical Trials
37,788 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe mental health condition like psychosis, major depression, panic attacks, thoughts of self-harm, or addiction to substances.I am 18 years old or older.You have been practicing yoga, Tai Chi, or other mindfulness-based activities in the past six months.I do not have any serious health conditions like uncontrolled high blood pressure, glaucoma, or heart failure.I have type-2 diabetes and my condition is stable with medication.My BMI is over 45.I have complications from diabetes like eye, nerve, or kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Yoga
- Group 2: Standard Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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