Efficacy of Delta-Tocotrienol vs Placebo on control of blood glucose level in prediabetic patients – A randomized controlled trial
Phase 1
- Conditions
- Prediabetes
- Registration Number
- SLCTR/2019/024
- Lead Sponsor
- ational University of Medical Sciences Rawalpindi, Pakistan.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
* Both men and women
* Aged 18-60 years
* Participants who are diagnosed to have Prediabetic criteria: a. Impaired fasting plasma glucose level (5.6-6.9mmol/L) or/and b. Glycosylated hemoglobin (HbA1c) 5.7% to 6.4%
Exclusion Criteria
1.Cardiac patients
2.Pregnant or breast-feeding females
3.Critically ill patients
4. Acute stress/anxiety
5.Severe renal, liver or respiratory disease
5.Cancer patients
6.Those taking any medicine for glucose control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Improvement of glycemic control including mean reduction in measurement of fasting plasma glucose (mmol/L) and HbA1c (mmol/L) at 12 weeks with baseline values [At the baseline of the study and at 12 weeks after Delta-Tocotrienol supplementation (NS).]<br>
- Secondary Outcome Measures
Name Time Method Mean reduction in insulin resistance by measuring fasting blood glucose, (mmol/L), serum insulin (IU/L) and Homeostatic Model Assessment of Insulin Resistance (HOMA IR).<br> [At the baseline of the study and at 12 weeks after Delta-Tocotrienol supplementation (NS).]<br>