Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Pratiksha Trust
Eligibility
Inclusion criteria
Inclusion criteria: Participants of both the genders aged 40 to 65 years (upper limit to minimize differences in brain structural changes related to normal aging). 1. Participants who are not on any medication for cognitive health in the past 1 year. 2. Participants who have not taken any Ayurvedic intervention for DM. 3.BMI =30 (Obesity range). 4.Literate population (minimum 10th pass). 5.Participants (Type 2 DM) were on diabetes medication. 6.HbA1c levels should be more than 7 and less than 9. 7.Duration of Type 2 DM should be more than 2 Years. 8.Individuals should be able to cook a meal, shop, pay bills, etc., independently, even if they take longer or make errors scored using ADLQ. 9.Willing to sign the informed consent letter and participate in the study. Inclusion Criteria for Healthy controls: - 1.Participants of both the genders aged 40 to 65 years (upper limit to minimize differences in brain structural changes related to normal aging). 2.Literate population (minimum 10th pass) 3.Controls will be non-diabetic and healthy, without any neurological issues that would introduce brain injury or drug dependency (e.g., tobacco, cocaine), that would modify brain hemodynamics and brain tissue, age-(±2 years) and gender-matched with Type 2 DM participants.
Exclusion criteria
Exclusion criteria: 1.Recent ( 2.Patients who are on/ have taken (in past 2 years) Ayurveda medication. 3.Type 2 DM participants should not be on any medications which is known to impact neurological or cardiovascular functions. 4.BMI >30 (Obesity range). 5.Score of 5 and above on QDRS scale 6.Severe hearing or visual impairment which can alter cognitive test outcomes 7.Major psychological / psychiatric illness and on any anti-depressants, antipsychotic drug etc. for long term (more than 1 year) 8.Healthy controls having medical condition (i.e., Diabetes, Hypertension etc.) •For FMRI participants: Claustrophobia, metallic-based tattoos, metallic implants or devices (e.g., implantable cardioverter-defibrillator [ICD], pacemaker, embolic coils, aneurysm clips), or any other material which could be hazardous in the fMRI scanner 9.Trauma: Head injury, in the past 1 year 10.Severe drug/alcohol addicts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cognitive functions & related parameters at the baseline & at the end of the intervention or control period. The assessment will be done by using standardized neuropsychological assessments & questionnaires fMRI & blood parameters or metabolomics.Timepoint: 2 year 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in cognitive functions, in Type 2 DM patients, at the baseline, compared to healthy controls, using above mentioned techniques.Timepoint: 2 year 6 months | — |
Countries
India
Contacts
Public ContactDr Bhargavi P
The University of Transdisciplinary Health Sciences and Technology (TDU)
Outcome results
None listed