Assessment of Yoga asanas in patients with type 2 diabetes and NAFLD on quality of life.
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2024/03/064485
- Lead Sponsor
- Charu Paliwal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
A man or woman 30-60 years old both inclusive who has been diagnosed with T2DM and NAFLD
Based on their medical history physical examination and laboratory tests participants must be medically stable
Participants must be capable of and willing to follow prohibitions and guidelines outlined in this protocol
Each participant must sign an informed consent form ICF attesting to their understanding of the studys goals and their willingness to take part in the study
Participant with fibroscan grading from 0 to 2
Participant with HbA1c between more than 7 to 10
A physical condition that significantly limits mobility wheelchair waking aid walking stick, cane or crutches)
Participant on insulin therapy
Trying to conceive or currently pregnant women or pregnant women with gestational diabetes
Highly uncontrolled diabetes HbA1c more than 10.0 percent
Evidence of other forms of liver disease apart from NAFLD or other chronic disease
Prior history of gastric bypass surgery or any other surgery
Recent start of any SGLT-2 inhibitor within 90 days of randomization or recent initiation or change of any anti-diabetic medication that affects liver fat
8.Participation in a weight loss/diet programme within 12 months of the screening or usage of prescription or over-the-counter weight-loss medication within 3 months of the screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact of yoga asanas, on QOL in patients of T2DM with NAFLD.Timepoint: At 3 months,6 Months, 9 Months and 12 months.
- Secondary Outcome Measures
Name Time Method To assess the impact of yoga asanas, on quality of life and biochemical parameters of diabetes (FBS, PPBS & HbA1c) and NAFLD (ALT & AST) <br/ ><br>Timepoint: Month 3,6,9 and 12;To assess the percentage of weight loss in patients withT2DM with NAFLDTimepoint: Month 3,6,9 and 12;To estimate the impact of Yoga asanas, on fibroscan in participants of NAFLD with diabetesTimepoint: Month 6 and 12