ISRCTN11690727Completed未知

Modulation of physiological and biochemical parameters by controlled vestibular stimulation in prediabetes and Type 2 diabetes mellitus

ittle Flower Hospital and research centre0 sites240 target enrollmentStarted: November 13, 2019Last updated: June 7, 2021

Conditions

Trial Snapshot

•Current inclusion criteria as of 19/05/2021:
•Pre-Diabetic patients:
•1. Fasting blood glucose level between 100 mg/dl and 125 mg/dl or HbA1C between 5.7% and 6.4%
•2. Male and female patients aged 30-60 years
•Diabetic patients:
•3. Fasting blood glucose level >126 mg/dl or HbA1C >6.4% or taking oral hypoglycemic agents or insulin
•4. Male and female patients aged 30-60 years
•Previous inclusion criteria:
•Pre-Diabetic patients:
•1. Fasting blood glucose level between 100 mg/dl and 125 mg/dl or HbA1C between 5.7% and 6.4%
•2. Male and female patient with age 20 - 70 years
•Diabetic patients:
•3. Fasting blood glucose level >126 mg/dl or HbA1C >6.4% or taking oral hypoglycemic agents or insulin
•4. Male and female patient with age 20 - 70 years

•1. Type 1 diabetes mellitus or gestational diabetes mellitus
•2. Undergone any vestibular stimulation programs
•3. Critically ill
•4. Diagnosed with any cardiac diseases, cerebrovascular, renal diseases and liver diseases
•5. On oral medication for hypertension and hyperlipidemia
•6. Any planned surgery during the course of study
•7. Pregnant or planning to get pregnant during the course of study
•8. Taking vitamin supplements
•9. Chronic smokers and severe alcoholic
•10. Current continuous renal replacement therapy
•11. Current use of steroids
•12. Previous or current treatment with deep brain stimulation
•13. Previous known disease, injury, or surgical intervention involving the brain or central nervous system
•14. Moderate or greater hearing loss or presence of a cochlear implant
•15. Diagnosed vestibular dysfunction
•16. Any history of previous ear or eye surgery
•17. Active ear infections or a perforated tympanic membrane
•18. Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Sponsor

ittle Flower Hospital and research centre