Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients between 18-65 years of age of both genders. Participant with type 2 diabetes. HbA1c levels greater than or equal to 6.5 and less than or equal to 11 Participant on 1-3 marketed oral antidiabetic medications Willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Individuals with type 1 diabetes. Pregnant or breastfeeding women. Severe cognitive impairment or psychiatric conditions that could interfere with participation. Diabetic complications like CVD, diabetic neuropathy, diabetic nephropathy, and foot problem Patients with severe chronic kidney disease. Patients with a history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary. Angioplasty/stent within 6 months of study start. Patients having suffered cerebrovascular event within 6 months of start of study. Patients with cardiac failure categorized as Class III or IV as per New York Heart Association Functional Classification.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels from baseline to the end of the study period (3 months) between the intervention (Dia Booster) and control arm.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the fasting plasma glucose and postprandial plasma glucose, lipid profile, weight, and blood pressure from baseline to the end of the study.Timepoint: 3 Months | — |
Countries
India
Contacts
Madras Diabetes Research Foundation