Study to Determine the Effect of Trucrose in Patients with Type II Diabetes Mellitus
Not Applicable
Completed
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/07/026346
- Lead Sponsor
- Trulit Herbals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Adult, both male and female patients with Type 2 DM with fasting blood sugar between 120 and 200mg/dL
2.Those who are not avoiding oral intake of sugar
3.Be geographically accessible for follow up
4.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed
Exclusion Criteria
1.Preganancy or child bearing ptetntial who are at risk of pregancy
2.Patients with recent stroke or heart attack
3.Fasting blood sugar >200mg/dL
4.Limited life expectancy
5.Patients with rasied Blood Urea and Cretainine or clinical suspicion of Diabetic Neuropathy
6.Recent minor/major surgeries
7.Alcoholic subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the HbA1C (%) from baseline to end of studyTimepoint: Baseline and End of the Study
- Secondary Outcome Measures
Name Time Method Change in Serum insulin levels from baseline to end of the studyTimepoint: Baseline and End of the Study;Change in the lipid variables (TC, TG, LDL-C, HDL-C)Timepoint: Baseline and End of the Study;Changes in FPG and 2 hr PPG from baseline to end of the studyhTimepoint: Baseline, Week-2, week-4, week-8 and week-12