Prediabetes and Type 2 Diabetes Mellitus Nutritional, Metabolic, Endocrine Diabetes Mellitus
Conditions
Interventions
Prediabetic patients and Type 2 diabetic patients were randomly divided into experimental and control groups by block randomization with equal numbers of patients in each group.
Contr
Sponsors
Little Flower Hospital and research centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose levels measured using fasting blood sugar and HbA1c at baseline and three months | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and three months: 1. Anthropometry: 1.1. Waist to Hip Ratio (cm) 1.2. Body Mass Index (BMI) (kg/m²) 2. Physiological variables: 2.1. Heart rate (bpm) 2.2. Blood pressure (mmHg) 2.3. SPO2 3. Anxiety level measured using the stress assessment questionnaire - STAI (State Trait Anxiety Inventory) 4. Lipid profile (blood test): 4.1. Total Cholesterol (TC) 4.2. High Density Lipoprotein (HDL) 4.3. Low Density Lipoprotein (LDL) 4.4. Very Low Density Lipoprotein (VLDL) 4.5. Triglycerides (TG) 4.6. TC/HDL Ratio 5. Oxidative stress markers (blood test): 5.1. Malondialdehyde level (MDA) (spectrophotometric method) 5.2. Superoxide dismutase (SOD) (spectrophotometric method) | — |
Countries
India
Contacts
Public ContactRemya Paul
Outcome results
None listed