Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 20 to 60 years. Diagnosed with type 2 diabetes for more than 6 months. On stable antidiabetic drug regimen and no change for more than 6 months Baseline HbA1c 7 to 10 per cent BMI greater than 23 kg per meter square. According to the Endocrine Society of India, a BMI greater than 23 is considered overweight, and a BMI greater than 25 is considered obesity. Patient giving informed consent
Exclusion criteria
Exclusion criteria: Use of any extra supplement like psyllium or viscous fiber within 4 weeks. Significant renal eGFR less than 45, chronic liver disease, recent cardiovascular events, pregnancy and lactation. Any known history of GI malabsorption, inflammatory bowel disease . Known intolerance of oats or barley Patient refuses to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Epidemiological data like Age, Sex, Address, Duration of diabetes, Current medications, Comorbidities hypertension, dyslipidemia 2. Clinical data like BMI, Waist circumference, waist: hip ratio, HbA1C, Lipid profile, ECG, Complete hemogram, AST, ALT or LFT Urine spot ACR. Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma glucose, insulin, lipid profile (TC, LDL, HDL, TG). Timepoint: From baseline to 12 weeks; Anthropometrics: weight, BMI, waist circumference. Hip circumferences, waist hip ratio.Timepoint: 120 weeks; Adverse events and tolerabilityTimepoint: | — |
Countries
India
Contacts
School of Tropical Medicine