Cognitive functions in Type-2 Diabetes Patients following yoga practice

Phase 1

• Conditions: Health Condition 1: null- Type 2 Diabetes

• Registration Number: CTRI/2017/12/010936
• Lead Sponsor: Ministry of AYUSH CCRY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Diagnosed with T2DM according to the 2010 criteria of the American Diabetes Association (ADA),

2)no T2DM-related complications, including diabetic retinopathy, diabetic nephropathy, diabetic neuropathy and diabetic foot,

3)no history of hypoglycemia during the last two years,

4)Patients that did not practice Yoga in the last 3 months,

5)Not enrolled in any other alternative medicine programs,

6)Male and female subjects will be studied with cognitive task performance,

7)Willingness to participate in the trial

Exclusion Criteria

1) Mini-Mental State examination (MMSE) scoreâ?? <â??27; 2)

2) BMIâ??>=â??30â??kg/m2

3) The presence of cognitive or neurological disorders, based on a medical history and routine clinical examination. In addition, the following two tests would be used:

(i) patients with pregnancy,

(ii) physical or mental disability to do Yoga,

(iii) history of drug, alcohol, or chemical abuse within 6 months prior to screening,

(iv) patients with any surgical organic disease, and

(v) inability to comply with study and follow-up procedures.

4) The presence of a behavioral/psychological disorder: (i) the presence of behavioral/psychological impairments will be assessed using the Symptom Checklist-90-R (SCL-90-R). Subjects with significant deviations (exceeding one standard deviation) on these instruments will be excluded from the study.

(ii)Intake of medication, which is known to influence cognitive or autonomic functions.

5) Smoking or alcoholism which may influence cognitive functions, sensory and motor variables.

6) cerebrovascular events, including transient ischemic attack and stroke.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) This study will establish a baseline of neural activity, cerebral blood flow changes and psychophysiological changes in Type 2 Diabetes Mellitus patients. <br/ ><br>2)This will be a good start of understanding and explore mechanism of brain role in the management of Type 2 Diabetes and association with other disorders such as anxiety, depression, quality of sleep, and food habit.Timepoint: Initial Phase of the study would assess the baseline then, mid assessment will be taken after 45 days of intervention and post assessment will be taken after 90 days of intervention.

Secondary Outcome Measures

Name	Time	Method
The outcome of this study will be disseminated in layman language for general public awareness. <br/ ><br>This may also control the Type 2 diabetes related psychological, physiological and neurological problems and may enhance cognitive functions. <br/ ><br>The outcome of the project will be published in high impact factor Neuroscience journalsTimepoint: This study will establish a baseline of neural activity, cerebral blood flow changes and psychophysiological changes in Type 2 Diabetes Mellitus patients. <br/ ><br>This will be a good start of understanding and explore mechanism of brain role in the management of Type 2 Diabetes and association with other disorders such as anxiety, depression, quality of sleep, and food habit.