Health Condition 1: null- Pre-diabetes
Conditions
Interventions
Intervention1: Individualized homoeopathic medicine along with life style modification: Individualized Homoeopathic treatment will be given to the patients in potency and dose as per the requirement
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: • Indian diabetic risk score(IDRS) more than equal to 60 • Adults above 35 years with impaired glucose regulation (2hrs oral glucose tolerance test with 75 g glucose load more than equal to 140 mg per dL and ,less than 200 mg per dl, fasting plasma glucose concentration of 6.1mmol/L ( >110 mg/dL) or greater but less than 7.0 mmol per L (126mg per dL) as recommended by WHO (1999). • Patients who are negative on Glutamic acid Decarboxylase (GAD) antibodies and insulin antibodies • Written informed consent
Exclusion criteria
Exclusion criteria: • Self reported HIV positivity • Self reported cardiovascular disease such as bundle block, uncontrolled hypertension (SBP >180 mmHg or DBP >105 mmHg on treatment). Milder degrees of hypertension would prompt referral to primary care provider for treatment but would not exclude. • Stroke or transient ischemic attack in the past 6 months • Recent or significant abdominal surgery (e.g. gastrectomy) during last six months. • Unable or unwilling to give informed consent and comply with study protocol • Likely to move away from participating clinics in next 01 year • Pregnancy and Lactating mother • Major psychiatric disorder which would impede conduct of the study • Excessive alcohol intake, either acute or chronic. Those patients who are taking 60 ml in case males and 30 ml in case of females per day • Diabetes at baseline evaluation evidenced by any of the following: ï? Fasting blood glucose 126 mg/dL [7.0 mmol/L] ï? 2-hour blood glucose 200 mg/dL [11.1 mmol/L] based on 75 gm OGTT ï? Diabetes diagnosed by a physician and confirmed by other clinical data (e.g. documentation of a fasting ï? Plasma glucose 126 mg/dL [7.0 mmol/L] or a positive OGTT • Ever used hypoglycemic medication (oral agents or insulin; except during GDM) i.e. in the last six months any medication which would affect the blood glucose metabolism will be excluded (corticosteroids, oral agents, insulin). • Any systemic illness to be excluded (LFT, KFT). • TSH test to exclude sub clinical and clinical hypothyroidism at baseline. • Self reported thyroid disease, sub optimally treated. • Patientsâ?? positive for GAD and insulin antibodies will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the changes in impaired glucose regulation through â?¢ Insulin sensitivity (CLIX) â?¢ Beta-cell function (HOM-IR)Timepoint: To evaluate the changes in impaired glucose regulation through â?¢ Insulin sensitivity at month 6(CLIX) â?¢ Beta-cell function at month 6 (HOM-IR) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes in â?¢ AUC FBG at month 1,2,3,4,5, & 6 â?¢ AUC PPBG at 1,2,3,4,5, & 6 â?¢ 2hrs oral glucose tolerance at month6 from baseline â?¢ Fasting C-peptide at month 6from baseline â?¢ HbA1c at month 6from baseline â?¢ Fasting plasma insulin at month 6from baseline â?¢ BMI at month 6from baseline â?¢ Lipid profile at month 6from baseline â?¢ Quality of life using WHO QOL â??Bref at month 6from baselineTimepoint: 6th month | — |
Countries
India
Contacts
Public ContactDr Varanasi Roja
Central Council for Research in Homoeopathy
Outcome results
None listed