Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Overweight/obese patients with or without diabetes (BMI= 25 kg/m2) between ages 18-65 years. 2. Participants who are willing to provide written informed consent. 3. Participant who are willing to follow suggested dietary intervention, and other prescribed guidelines.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes. 2. Type2diabetic with severe complication like; heart failure(grade 3-4), CKD etc 3. Patients with advanced renal, hepatic or cardiac disease, cancer. 4. Patients with genetic predisposition to metabolic disorders. 5. Any history of hypersensitivity with stevia glycoside and other components in the test products or an adverse reaction that might affect the study. 6. Women who are pregnant or lactating. 7. Refusal to sign an informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess effectiveness of “GUUD test product ? compared to quantity match normal sugar in improving glycemic variability and metabolic function in overweight/obese diabetic and nondiabetic subjects by assessing biochemical investigations.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes shall be reported by analyzing changes in BMI, waist circumference, hip circumference and cardiovascular risk.Timepoint: 6 months | — |
Countries
India
Contacts
Eternal Heart Care Centre and Research Institute