“Effect of Yoga on Cardiovascular & Biochemical parameters in Prediabetes

Phase 1

Not yet recruiting

• Conditions: prediabetes

• Registration Number: CTRI/2017/06/008825
• Lead Sponsor: RUHS college of medical sciences jaipur

Brief Summary

**Title of the Research Project**

**“****EFFECT OF INTEGRATED APPROACH OF YOGA THERAPY ON   CAROTID INTIMA MEDIA THICKNESS  , HEART RATE VARIABILITY &  BIOCHEMICAL PARAMETERS  IN PREDIABETES****â€**

 **Objectives-**

The objectives of the study are as follows: -

1.    To study effect of yoga on carotid artery intima media thickness as an early indicator of atherosclerosis in prediabetes.

2.    To study effect of yoga on heart rate variability in prediabetes.

3.    To study effect of yoga on biochemical parameters  like   blood glucose, glycated HbA1C &  serum lipid profile in prediabetes.

4.   To evaluate the   effect of yoga on prediabetes and use it as a tool for primary prevention.

**Design of the study—** **PROSPECTIVE COMPARITIVE   STUDY**

Mode of Selection of Subjects:

**Source of data**

1. First degree relatives of diabetics

2.      Newly diagnosed cases of prediabetecs

3.      Patients attending general medicine outpatient section

**Sample size**: 250

As the prevalence of diabetes in India is 8% taking it as a reference the sample size is calculated using the appropriate size formula z2pq/d2 where p & q were taken as .08 and .92 to get the maximum sample size with 5% permissible error(precision ) and 10% non response rate the desired sample size is 125 with 95% confidence interval.

**Methodology:**

**Interventions**

The Integrated Approach  of Yoga Therapy  includes Prayer, Omkar recitation, yoga postures (asanas), breathing (pranayama), Shavasana ,Counseling and diet will  also be part of the programme.

Yoga  will be  used as an interventional therapy in this study. Yoga training will be given by certified yoga instructor and all investigations shall be checked on monthly basis. These sessions will last for approximately 45 minutes two  times a week over a period of one year. All the cases will be   given  cd  of integrated approach of  yoga  therapy  &  e message and phone calls on  daily basis  to check the compliance of patients. Evaluation will be done  quarterly basis.

**Cardiovascular Parameters**

**HRV PARAMETERS**

**Biochemical parameters**

**Expected Benefits from the study**:

However, this type of intervention study has not been done in prediabetes of Rajasthan population . Therefore, this case control intervention   will determine the  efficacy  of yoga on Prediabetes  in  the state of Rajasthan

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-17
• Last Update Posted: 2017-08-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 1.Ambulatory participants aged 30 to 50years 2.All subjects with Fasting blood glucose level of: 110 to 125 mg/dL (6.1 mM/L to 6.9 mM/L) & Two hour glucose tolerance test , blood sugar level of 140 to 199 mg/dL (7.8 to 11.0 mM) ,hemoglobin A1c (HbA1c) levels 5.5% to 6.5% any of the above two parameters will include .
• 3.no personal history of cardiovascular disease, no cardiovascular disease in the first-degree relatives, and serious illness requiring admission to hospital in the past year.

Exclusion Criteria

• 1.Fasting blood glucose < 100mg/dl & >126 mg/dl , OGTT < 140 & >200 mg/dl glycated hemoglobin < 5.5% & > 6.5% systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg 2.
• Abnormal liver function test (alanine aminotransfer¬ase [ALT] or aspartate aminotransferase [AST] ≥ 2.5-fold the upper normal limit 3.
• Alcoholic individuals (weekly alcohol consumption ≥ 140 g).
• Renal dysfunction, diabetic retinopathy and neuropathy and any other major complications.
• 5.Those being treated with steroid or non-steroidal anti-inflammatory medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
4.Practice of comprehensive yogic breathing had beneficial effects on cardiac autonomic functions in prediabetes. Since cardiac dysfunction has been implicated in sudden cardiac death in diabetes, this finding may translate to practice of yogic breathing program being useful in delaying sudden cardiac death.	two year

Secondary Outcome Measures

Name	Time	Method
6. Studies has been established practice of comprehensive yogic breathing program significantly improves physical, psychological, and social domains, and total quality of life. In view of the existing knowledge and yoga being a cost ‑effective technique without side effects, it appears appropriate to incorporate yoga/meditation for primary and secondary prevention of cardiovascular disease.	2 years

Trial Locations

Locations (1)

RUHS COLLEGE OF MEDICAL SCIENCES AND JAIPURIA HOSPITAL; 🇮🇳 Jaipur, RAJASTHAN, India

RUHS COLLEGE OF MEDICAL SCIENCES AND JAIPURIA HOSPITAL

🇮🇳Jaipur, RAJASTHAN, India

DRNEHA SABOO

Principal investigator

9928053007

nehasaboo8@gmail.com