Evaluating safety and efficacy of zinc ang magnesium supplements in Type 2 diabetic patients along with standard care of treatament
Phase 3
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/07/071237
- Lead Sponsor
- Dr Santra Sunny (self)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients diagnosed with Type 2 Diabetes Mellitus.
Patients willing to informed consent.
Exclusion Criteria
Type 1 diabetic patient and patient on Insulin
Pregnancy, diabetic ketoacidosis
A cardiovascular event in the 3 months before enrolment
Moderate or severe impairment of renal function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c from baseline.Timepoint: eighteen months
- Secondary Outcome Measures
Name Time Method -The change from baseline to week 24 in fasting plasma glucose (FPG) <br/ ><br>-The change from baseline to week 24 in postprandial blood sugar (PPBS) <br/ ><br>-The change from baseline to week 24 in Body mass Index / weight/waist circumference. <br/ ><br>-The change from baseline to week 24 in Lipid profile. <br/ ><br>-The change from baseline to week 24 in Renal function test. <br/ ><br>-Mean changes from baseline in systolic (SBP) and diastolic blood pressure (DBP) at week 24. <br/ ><br>Timepoint: eighteen months