Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of both gender with fasting blood sugar more than 150 mg per dl and post prandial blood sugar more than 250 mg per dl 2. Drug naive or patients on monotherapy for treatment of diabetes more than 2 weeks 3. Subjects willing to voluntarily participate in the study by giving their informed consent and willing to follow protocol procedures
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Gestational Diabetes Mellitus 3. Patient with history of recent MI 4. Patient with acute dyspepsia 5. Known allergy to the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decrease from baseline to study end in: a. Fasting Blood Glucose b. Post-prandial blood glucose levels c. Post prandial Insulin d. Capillary Blood sugarTimepoint: a. Fasting Blood Glucose for 14 days b. Post-prandial blood glucose levels at 120 min post consumption of Resistant Starch enriched Cookies for 14 days c. Post prandial Insulin before the initiation of the study and once after the completion of the 14 days trial d. Capillary Blood sugar taken at 0 min, 30 min, 60 min, 90 min and 120 min post consumption of Resistant Starch enriched Cookies for 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Decrease in BMI and waist circumference from baseline to improvement end 2. Decrease in triglycerides, low density lipoprotein and increase in high density lipoprotein from baseline to study endTimepoint: Once before the study and once after the completion of the 14 days trial | — |
Countries
India
Contacts
Indian Institute of Technology Kharagpur