Diabetes Mellitus, Non-Insulin-DependentNCT02661906
A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days
A study testing SKY in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- SKY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteKuwait
- Study dates
- Aug 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients showing stress as per the stress indicators.
- Patients of both gender of age 30 to 65 years on oral anti diabetic agents
- Patient is able to perform yoga postures and breathing exercise.
- Patient is able to consent for the study.
- Patient should be able to understand English as that is the medium used.
Who cannot join
- Bipolar disorder
- Antidepressant drugs
- Type 1 diabetes
- Pregnancy
- Any acute coronary symptoms in past 6 months
- Artificial pace-maker
- Previous (SKY) or any type of spiritual meditation practiced within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of SKY on Anxiety, Depression and Quality of Life of Type 2 Diabetic Patients After a 6 Days Intervention
The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.
Read the detailed description
Diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial factors are relevant to nearly all aspects of its management. Research findings have demonstrated that depression is more common in patients with diabetes than in the general population, at least 15 % of patients have clinical depression.Yoga is a mind-body alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and related complications.
Sudarshan kriya Yoga is a unique yogic breathing practices which involves several types of cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. It is recommended for relaxation, stress management, control of psycho physiological states and to improve organ function. In this pilot study Investigator recruited 24 type 2 diabetic patient and those who consent were provided with 6 days yoga course for a duration of 3 hours and trained to practice SKY at home for 12 week. At baseline and after 6 days of SKY, questionnaire on anxiety, depression and quality of life were provided to them. Biochemical parameters were measured at baseline and after 12 weeks of yoga. Two follow up yoga session were provided to the participants. Primary outcome were pre to post intervention change in the mental health and quality of life.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- SKY
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKYOther
Sudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool. SKY is having effect on multiple organ thus causing the positive effect.
| Study group | Role | What they receive |
|---|---|---|
| SKY Pre | Experimental | Sudarshan Kriya Yoga is provided to all the enrolled participants. The baseline characteristics of patient is compared with that of their characteristics after yoga intervention. All the participants were provided with yoga training for 6 days and then asked to perform the SKY at home daily till 12 week. The questionnaire on anxiety, depression and quality of life were administered at the baseline and at the end of 6 days of yoga. Biochemical parameters such as HbA1c, lipid profile, fasting glucose and post meal glucose were measured at baseline and after 12 week of intervention. Receives: Other: SKY |
| SKY post | Active comparator | The enrolled participants were provided with SKY intervention and their pre and post data were recorded. Receives: Other: SKY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in quality of life
change in score of Questionnaires on anxiety at 12 week of yoga intervention
Measured: at 12 week
Secondary outcomes (3)
Improvement in HbA1c
Change in HbA1c value at 12 week of yoga intervention
Measured: at12 week of intervention
Improvement in BMI
Change in BMI at 12 week of yoga intervention
Measured: at 12 week of intervention
Improvement in lipid profile
Change in lipid levels at 12 week of yoga intervention
Measured: at 12 week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rashmi Shiju, Mpharm, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661906
- Sponsor's protocol ID
- RA 2014-028
- Status last verified
- Aug 2016
- First submitted
- 8 Oct 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SKY on Anxiety, Depression and Quality of Life of Type 2 Diabetic Patients After a 6 Days Intervention
- ClinicalTrials.gov ID
- NCT02661906
- Acronym / sponsor ID
- RA 2014-028
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.
Detailed description
Diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial factors are relevant to nearly all aspects of its management. Research findings have demonstrated that depression is more common in patients with diabetes than in the general population, at least 15 % of patients have clinical depression.Yoga is a mind-body alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and related complications.
Sudarshan kriya Yoga is a unique yogic breathing practices which involves several types of cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. It is recommended for relaxation, stress management, control of psycho physiological states and to improve organ function. In this pilot study Investigator recruited 24 type 2 diabetic patient and those who consent were provided with 6 days yoga course for a duration of 3 hours and trained to practice SKY at home for 12 week. At baseline and after 6 days of SKY, questionnaire on anxiety, depression and quality of life were provided to them. Biochemical parameters were measured at baseline and after 12 weeks of yoga. Two follow up yoga session were provided to the participants. Primary outcome were pre to post intervention change in the mental health and quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKY Pre | Experimental | Other: SKYSudarshan Kriya Yoga is provided to all the enrolled participants. The baseline characteristics of patient is compared with that of their characteristics after yoga intervention. All the participants were provided with yoga training for 6 days and then asked to perform the SKY at home daily till 12 week. The questionnaire on anxiety, depression and quality of life were administered at the baseline and at the end of 6 days of yoga. Biochemical parameters such as HbA1c, lipid profile, fasting glucose and post meal glucose were measured at baseline and after 12 week of intervention. |
| SKY post | Active comparator | Other: SKYThe enrolled participants were provided with SKY intervention and their pre and post data were recorded. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients showing stress as per the stress indicators.
- Patients of both gender of age 30 to 65 years on oral anti diabetic agents
- Patient is able to perform yoga postures and breathing exercise.
- Patient is able to consent for the study.
- Patient should be able to understand English as that is the medium used.
Key exclusion criteria (7 listed)
- Bipolar disorder
- Antidepressant drugs
- Type 1 diabetes
- Pregnancy
- Any acute coronary symptoms in past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKYSudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool. SKY is having effect on multiple organ thus causing the positive effect. | Other | SKY Pre, SKY post |
Primary outcome
Improvement in quality of life
Time frame: at 12 week
change in score of Questionnaires on anxiety at 12 week of yoga intervention
3 secondary outcomes
Improvement in HbA1c
Time frame: at12 week of intervention
Improvement in BMI
Time frame: at 12 week of intervention
Improvement in lipid profile
Time frame: at 12 week of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Shiju, Mpharm principal investigator
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKY in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Dasman Diabetes Institute at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in quality of life (time frame: at 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.